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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01515787
Other study ID # N1048
Secondary ID CDR0000715321NCI
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 12, 2012
Est. completion date June 30, 2024

Study information

Verified date January 2024
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.


Description:

OUTLINE: This is a multicenter, phase II/III study. Patients are stratified according to ECOG performance status (0 or 1 vs 2) and randomized to 1 of 2 treatment regimens. Patients will receive full supportive care while on this study. OBJECTIVES: Primary 1. Phase II component: To assure that neoadjuvant FOLFOX followed by selective use of 5FUCMT group (Group 1) maintains the current high rate of pelvic R0 resection and is consistent with non-inferiority for time to local recurrence (TLR). 2. Phase III component: To compare neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) to standard 5FUCMT (Group 2) with respect to the primary endpoint of the Disease-Free Survival (DFS). Secondary 1. To determine if the neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) is non-inferior to the standard group 5FUCMT (Group 2) with respect to the proportion of patients who achieve a pathologic complete response (pCR) at the time of surgical resection. 2. To determine if the neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) is non-inferior to the standard 5FUCMT (Group 2) with respect to overall survival. 3. To evaluate and compare the adverse event profile and surgery complications between two groups. 4. To estimate the proportion of patients in the selective group (Group 1) who receive: 1) pre-operative 5FUCMT; 2) post-operative 5FUCMT; 3) either pre- or post-operative 5FUCMT. 5. To determine if the neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) is non-inferior to the standard 5FUCMT (Group 2) with respect to Local Recurrence (TLR) 6. To determine if the neoadjuvant FOLFOX followed by selective use of 5FUCMT (Group 1) is non-inferior to the standard 5FUCMT (Group 2) with respect to Neoadjuvant Response Score (NAR) Event monitoring of patients will continue up to 8 years post randomization.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1194
Est. completion date June 30, 2024
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Registration Inclusion Criteria: 1. Age = 18 years at diagnosis 2. Diagnosis of rectal adenocarcinoma 3. Radiologically measurable or clinically evaluable disease as defined in the protocol 4. ECOG Performance Status (PS): 0, 1 or 2 5. For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection 6. Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon 7. Primary surgeon is credentialed or is willing to be credentialed in Total Mesorectal Excision (TME), which entails submission of photos of a single TME specimen either before enrolling the first patient or by using the surgeon's 1st accrued case. 8. Clinical Stage: T2N1, T3N0, T3N1. - N2 disease is to be estimated as four or more lymph nodes that are = 10 mm. - Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT or PET/CT scan of the chest/abdomen/pelvis and either a pelvic MRI or an ultrasound (ERUS). If a pelvic MRI is peformed, it is acceptable to perform CT of the chest/abdomen, ommitting CT imaging of the pelvis. 9. The following laboratory values obtained = 28 days prior to registration: - Absolute neutrophil count (ANC) = 1500/mm^3 - Platelet count = 100,000/mm^3 - Hemoglobin > 8.0 g/dL - Total bilirubin = 1.5 x upper limit of normal (ULN) - SGOT (AST) = 3 x ULN - SGPT (ALT) = 3 x ULN - Creatinine =1.5 x ULN 10. Negative pregnancy test done = 7 days prior to registration, for women of childbearing potential only 11. Patient of child-bearing potential is willing to employ adequate contraception 12. Provide informed written consent 13. Willing to return to enrolling medical site for all study assessments Registration Exclusion Criteria: 1. Clinical T4 tumors 2. Primary surgeon indicates need for abdominoperineal (APR) at baseline 3. Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins) 4. Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible). 5. Chemotherapy within 5 years prior to registration. Hormonal therapy is allowable if the disease free interval is = 5 years. 6. Any prior pelvic radiation 7. Other invasive malignancy = 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix. 8. Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception 9. Co-morbid illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
FOLFOX (chemotherapy)
Oxaliplatin 85 mg/m^2 IV over 2 hours on day 1, leucovorin 400 mg/m^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m^2 bolus over 5-15 minutes then 2400 mg/m^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.
Other:
5 FUCMT (chemoradiation)
5-fluorouracil 225 mg/m^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.
Procedure:
surgery
low anterior resection with total mesorectal excision
magnetic resonance imaging or endorectal ultrasound


Locations

Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta
Canada PEI Cancer Treatment Centre-Queen Elizabeth Hospital Charlottetown Prince Edward Island
Canada Cross Cancer Institute Edmonton Alberta
Canada BCCA-Cancer Centre for the Southern Interior Kelowna British Columbia
Canada London Regional Cancer Program London Ontario
Canada McGill University Department of Oncology Montreal Quebec
Canada The Research Institute of the McGill University Health Centre (MUHC) Montreal Quebec
Canada Lakeridge Health Oshawa Oshawa Ontario
Canada Ottawa Hospital and Cancer Center-General Campus Ottawa Ontario
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Niagara Health System-Saint Catharines General Saint Catharines Ontario
Canada Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John New Brunswick
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto Ontario
Canada BCCA-Vancouver Cancer Centre Vancouver British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
Israel Shaare Zedek Medical Center Jerusalem
Switzerland Kantonsspital Aarau Aarau
Switzerland University Hospital Basel Basel
Switzerland Oncology Institute of Southern Switzerland Bellinzona
Switzerland Kantonsspital Graubunden Chur
Switzerland University Hospital of Lausanne Lausanne
Switzerland Kantonsspital Winterthur Winterthur
Switzerland Zurich Hirslanden Klinik Zurich
Switzerland Zurich Im Park Zurich
United States Hawaii Oncology Inc-Pali Momi 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Abington Memorial Hospital Abington Pennsylvania
United States Summa Akron City Hospital/Cooper Cancer Center Akron Ohio
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Florida Hospital Cancer Institute Altamonte Altamonte Springs Florida
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah
United States Community Hospital of Anaconda Anaconda Montana
United States Cancer Care Center at Island Hospital Anacortes Washington
United States Kaiser Permanente-Anaheim Anaheim California
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Regional Hospital Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States PCR Oncology Arroyo Grande California
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Hematology Oncology Associates of Central New York-Auburn Auburn New York
United States MultiCare Auburn Medical Center Auburn Washington
United States Sutter Auburn Faith Hospital Auburn California
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States University of Colorado Hospital Aurora Colorado
United States Dell Seton Medical Center at The University of Texas Austin Texas
United States Mount Sinai Comprehensive Cancer Center at Aventura Aventura Florida
United States Virginia Mason Bainbridge Island Medical Center Bainbridge Island Washington
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States MedStar Good Samaritan Hospital Baltimore Maryland
United States MedStar Union Memorial Hospital Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Summa Barberton Hospital Barberton Ohio
United States Flaget Memorial Hospital Bardstown Kentucky
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge Louisiana
United States Southside Hospital Bay Shore New York
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States UPMC-Heritage Valley Health System Beaver Beaver Pennsylvania
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States UM Upper Chesapeake Medical Center Bel Air Maryland
United States Nebraska Medicine-Bellevue Bellevue Nebraska
United States Overlake Hospital Medical Center Bellevue Washington
United States Swedish Cancer Institute-Eastside Oncology Hematology Bellevue Washington
United States Kaiser Permanente-Bellflower Bellflower California
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa
United States Beverly Hospital Beverly Massachusetts
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Deaconess Hospital Bozeman Montana
United States Cox Cancer Center Branson Branson Missouri
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Harrison Medical Center Bremerton Washington
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States United Hospital Center Bridgeport West Virginia
United States IHA Hematology Oncology Consultants-Brighton Brighton Michigan
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Maimonides Medical Center Brooklyn New York
United States Henry Ford Cancer Institute-Downriver Brownstown Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
United States Mills-Peninsula Medical Center Burlingame California
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States University of Vermont College of Medicine Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cooper Hospital University Medical Center Camden New Jersey
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Aultman Health Foundation Canton Ohio
United States IHA Hematology Oncology Consultants-Canton Canton Michigan
United States Illinois CancerCare-Canton Canton Illinois
United States Mercy Medical Center Canton Ohio
United States Saint Joseph Mercy Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States IU Health North Hospital Carmel Indiana
United States Caro Cancer Center Caro Michigan
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Rocky Mountain Oncology Casper Wyoming
United States East Bay Radiation Oncology Center Castro Valley California
United States Eden Hospital Medical Center Castro Valley California
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Carolina Surgical Clinic of Charlotte PA Charlotte North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Oncology Specialists of Charlotte Charlotte North Carolina
United States Southern Oncology Specialists-Charlotte Charlotte North Carolina
United States Sentara Martha Jefferson Hospital Charlottesville Virginia
United States University of Virginia Cancer Center Charlottesville Virginia
United States Memorial Hospital Chattanooga Tennessee
United States IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Saint Luke's Hospital Chesterfield Missouri
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States Hematology and Oncology Associates Chicago Illinois
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Mount Sinai Hospital Medical Center Chicago Illinois
United States Northwestern University Chicago Illinois
United States Presence Resurrection Medical Center Chicago Illinois
United States Presence Saint Joseph Hospital-Chicago Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Swedish Covenant Hospital Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Feather River Cancer Center Chico California
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc - Anderson Cincinnati Ohio
United States Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio
United States Oncology Hematology Care Inc-Eden Park Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Oncology Hematology Care Inc-Mercy West Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States University of Cincinnati/Barrett Cancer Center Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Oncology and Hematology Care Southeast Clackamas Oregon
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Case Western Reserve University Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Greenville Health System Cancer Institute-Laurens Clinton South Carolina
United States Sampson Radiation Oncology Clinton North Carolina
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Community Cancer Institute Clovis California
United States University Oncology Associates Clovis California
United States AdventHealth Infusion Center Haywood Clyde North Carolina
United States Big Horn Basin Cancer Center Cody Wyoming
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Medical Center Coeur d'Alene Idaho
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States University of Missouri - Ellis Fischel Columbia Missouri
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States John B Amos Cancer Center Columbus Georgia
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States John Muir Medical Center-Concord Campus Concord California
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
United States Baptist Health Corbin Corbin Kentucky
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States UC Irvine Health Cancer Center-Newport Costa Mesa California
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Oncology Hematology Care Inc-Crestview Crestview Hills Kentucky
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Baylor University Medical Center Dallas Texas
United States Carle on Vermilion Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Southern Cancer Center PC-Daphne Daphne Alabama
United States Sutter Davis Hospital Davis California
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Beaumont Hospital-Dearborn Dearborn Michigan
United States Henry Ford Medical Center-Fairlane Dearborn Michigan
United States Atlanta VA Medical Center Decatur Georgia
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Delaware Radiation Oncology Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Colorado Blood Cancer Institute Denver Colorado
United States Denver Health Medical Center Denver Colorado
United States National Jewish Health-Main Campus Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States The Women's Imaging Center Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Epic Care-Dublin Dublin California
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Greenville Health System Cancer Institute-Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States Easton Hospital Easton Pennsylvania
United States HSHS Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Clinic Cancer Center - Eau Claire Eau Claire Wisconsin
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Mayo Clinic Health System Eau Claire Hospital-Luther Campus Eau Claire Wisconsin
United States Mayo Clinic Health System-Eau Claire Clinic Eau Claire Wisconsin
United States Fairview-Southdale Hospital Edina Minnesota
United States Swedish Medical Center-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Arnot Ogden Medical Center/Falck Cancer Center Elmira New York
United States Bay Area Breast Surgeons Inc Emeryville California
United States Epic Care Partners in Cancer Care Emeryville California
United States Walter Knox Memorial Hospital Emmett Idaho
United States Comprehensive Cancer Care and Research Institute of Colorado LLC Englewood Colorado
United States Englewood Hospital and Medical Center Englewood New Jersey
United States Swedish Medical Center Englewood Colorado
United States Saint Elizabeth Hospital Enumclaw Washington
United States Saint Vincent Hospital Erie Pennsylvania
United States The Regional Cancer Center Erie Pennsylvania
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Deaconess Clinic Downtown Evansville Indiana
United States Providence Regional Cancer Partnership Everett Washington
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Oncology Hematology Care Inc-Healthplex Fairfield Ohio
United States Inova Fairfax Hospital Falls Church Virginia
United States Roger Maris Cancer Center Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Clinic North-Fargo Fargo North Dakota
United States Beaumont Hospital - Farmington Hills Farmington Hills Michigan
United States Saint Francis Hospital Federal Way Washington
United States Virginia Mason Federal Way Medical Center Federal Way Washington
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin
United States Poudre Valley Hospital Fort Collins Colorado
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Holy Cross Hospital Fort Lauderdale Florida
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Fort Wayne Medical Oncology and Hematology Inc-Parkview Fort Wayne Indiana
United States Parkview Hospital Randallia Fort Wayne Indiana
United States Radiation Oncology Associates PC Fort Wayne Indiana
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Hematology Oncology Associates of Fredericksburg Inc Fredericksburg Virginia
United States Kaiser Permanente-Fremont Fremont California
United States Palo Alto Medical Foundation-Fremont Fremont California
United States Fresno Cancer Center Fresno California
United States Kaiser Permanente-Fresno Fresno California
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland Idaho
United States Fox Chase Cancer Center Buckingham Furlong Pennsylvania
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Saint Catherine Hospital Garden City Kansas
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Tacoma/Valley Radiation Oncology Centers-Gig Harbor Gig Harbor Washington
United States UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland
United States Glens Falls Hospital Glens Falls New York
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Mountain Blue Cancer Care Center Golden Colorado
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Wayne Radiation Oncology Goldsboro North Carolina
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Altru Cancer Center Grand Forks North Dakota
United States CHI Health Saint Francis Grand Island Nebraska
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Marin Cancer Care Inc Greenbrae California
United States Marin General Hospital Greenbrae California
United States UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States East Carolina University Greenville North Carolina
United States Greenville Health System Cancer Institute-Butternut Greenville South Carolina
United States Greenville Health System Cancer Institute-Eastside Greenville South Carolina
United States Greenville Health System Cancer Institute-Faris Greenville South Carolina
United States Greenville Memorial Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Rocky Mountain Cancer Centers-Greenwood Village Greenwood Village Colorado
United States Greenville Health System Cancer Institute-Greer Greer South Carolina
United States William Beaumont Hospital-Grosse Point Grosse Pointe Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Lymphoma Clinic of Michigan Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Yale-New Haven Shoreline Medical Center Guilford Connecticut
United States Gulfport Memorial Hospital Gulfport Mississippi
United States Sentara Cancer Institute at Sentara CarePlex Hospital Hampton Virginia
United States Memorial Sloan Kettering Westchester Harrison New York
United States Hartford Hospital Hartford Connecticut
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Ingalls Memorial Hospital Harvey Illinois
United States Saint Peter's Community Hospital Helena Montana
United States 21st Century Oncology-Henderson Henderson Nevada
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Edward Hines Jr VA Hospital Hines Illinois
United States Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee
United States Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Hawaii Cancer Care Inc-POB II Honolulu Hawaii
United States Hawaii Oncology Inc-Kuakini Honolulu Hawaii
United States Hawaii Oncology Inc-POB I Honolulu Hawaii
United States Island Urology Honolulu Hawaii
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States Ben Taub General Hospital Houston Texas
United States Lyndon Baines Johnson General Hospital Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States MD Anderson Regional Care Center-Katy Houston Texas
United States Methodist Willowbrook Hospital Houston Texas
United States Michael E DeBakey VA Medical Center Houston Texas
United States The Methodist Hospital System Houston Texas
United States Lake Norman Hematology Oncology Specialists-Huntersville Huntersville North Carolina
United States Southern Oncology Specialists-Huntersville Huntersville North Carolina
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States Huntington Hospital Huntington New York
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States Centerpoint Medical Center LLC Independence Missouri
United States Franciscan Health Indianapolis Indianapolis Indiana
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Kendrick Colon and Rectal Center-Indianapolis Indianapolis Indiana
United States Sidney and Lois Eskenazi Hospital Indianapolis Indiana
United States Springmill Medical Center Indianapolis Indiana
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Allegiance Health Jackson Michigan
United States Baptist MD Anderson Cancer Center Jacksonville Florida
United States Baptist Medical Center South Jacksonville Florida
United States Integrated Community Oncology Network-Southside Cancer Center Jacksonville Florida
United States Mayo Clinic in Florida Jacksonville Florida
United States Onslow Memorial Hospital Jacksonville North Carolina
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Integrated Community Oncology Network-Florida Cancer Center Beaches Jacksonville Beach Florida
United States Capital Region Southwest Campus Jefferson City Missouri
United States Jefferson Hospital Jefferson Hills Pennsylvania
United States UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania
United States Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Jupiter Medical Center Jupiter Florida
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Presence Saint Mary's Hospital Kankakee Illinois
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States The University of Kansas Cancer Center-North Kansas City Missouri
United States The University of Kansas Cancer Center-South Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States CHI Health Good Samaritan Kearney Nebraska
United States Heartland Hematology and Oncology Kearney Nebraska
United States Vidant Oncology-Kenansville Kenansville North Carolina
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Northwest Cancer Clinic Kennewick Washington
United States Tri-Cities Cancer Center Kennewick Washington
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States First Dayton Cancer Care Kettering Ohio
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Vidant Oncology-Kinston Kinston North Carolina
United States EvergreenHealth Medical Center Kirkland Washington
United States Seattle Cancer Care Alliance at EvergreenHealth Kirkland Washington
United States Florida Hospital Kissimmee Kissimmee Florida
United States Armstrong Center for Medicine and Health Kittanning Pennsylvania
United States Community Howard Regional Health Kokomo Indiana
United States UC San Diego Moores Cancer Center La Jolla California
United States IU Health La Porte Hospital La Porte Indiana
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Good Samaritan Medical Center Lafayette Colorado
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Lakeland Regional Health Hollis Cancer Center Lakeland Florida
United States The Watson Clinic Lakeland Florida
United States Monmouth Medical Center Southern Campus Lakewood New Jersey
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster Radiation Oncology Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States 21st Century Oncology Las Vegas Nevada
United States 21st Century Oncology-Fort Apache Las Vegas Nevada
United States 21st Century Oncology-Vegas Tenaya Las Vegas Nevada
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Cancer Therapy and Integrative Medicine Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States Desert West Surgery Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States OptumCare Cancer Care at Oakey Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States The University of Kansas Cancer Center-Lee's Summit Lee's Summit Missouri
United States Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas
United States Minimally Invasive Surgery Hospital Lenexa Kansas
United States Beebe Medical Center Lewes Delaware
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Saint Joseph Regional Medical Center Lewiston Idaho
United States Lewistown Hospital Lewistown Pennsylvania
United States Baptist Health Lexington Lexington Kentucky
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Liberty Radiation Oncology Center Liberty Missouri
United States NorthShore Hematology Oncology-Libertyville Libertyville Illinois
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Saint Mary Mercy Hospital Livonia Michigan
United States Logan Regional Hospital Logan Utah
United States Saint Joseph London London Kentucky
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States Monmouth Medical Center Long Branch New Jersey
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Cedars Sinai Medical Center Los Angeles California
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Los Angeles County-USC Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Baptist Health Louisville Louisville Kentucky
United States Jewish Hospital Louisville Kentucky
United States Jewish Hospital Medical Center Northeast Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Centra Lynchburg Hematology-Oncology Clinic Inc Lynchburg Virginia
United States Virginia Mason Lynnwood Medical Center Lynnwood Washington
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Baptist Health Madisonville/Merle Mahr Cancer Center Madisonville Kentucky
United States North Shore University Hospital Manhasset New York
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Mayo Clinic Health Systems-Mankato Mankato Minnesota
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Fairview Maple Grove Medical Center Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Bay Area Medical Center Marinette Wisconsin
United States OhioHealth Marion General Hospital Marion Ohio
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States Marshfield Medical Center Marshfield Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States WVUH-Berkely Medical Center Martinsburg West Virginia
United States Matthews Radiation Oncology Center Matthews North Carolina
United States Novant Health Cancer Specialists-Matthews Matthews North Carolina
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Loyola University Medical Center Maywood Illinois
United States UPMC Cancer Center at UPMC McKeesport McKeesport Pennsylvania
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Midstate Medical Center Meriden Connecticut
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Mountain States Tumor Institute - Meridian Meridian Idaho
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Mount Sinai Medical Center Miami Beach Florida
United States Woodland Cancer Care Center Michigan City Indiana
United States Dayton Physicians LLC-Signal Point Middletown Ohio
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Orange Regional Medical Center Middletown New York
United States Mid-Michigan Medical Center - Midland Midland Michigan
United States Bon Secours Saint Francis Medical Center Midlothian Virginia
United States Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford Massachusetts
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin
United States Providence Milwaukie Hospital Milwaukie Oregon
United States NYU Winthrop Hospital Mineola New York
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Minneapolis VA Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Memorial Regional Cancer Center Day Road Mishawaka Indiana
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Southern Cancer Center PC-Mobile Mobile Alabama
United States Southern Cancer Center PC-Providence Mobile Alabama
United States Southern Cancer Center PC-Springhill Mobile Alabama
United States University of South Alabama Mitchell Cancer Institute Mobile Alabama
United States Kaiser Permanente-Modesto Modesto California
United States Memorial Medical Center Modesto California
United States Garneau, Stewart C MD (UIA Investigator) Moline Illinois
United States Porubcin, Michael MD (UIA Investigator) Moline Illinois
United States Spector, David MD (UIA Investigator) Moline Illinois
United States Trinity Medical Center Moline Illinois
United States Monroe Cancer Center Monroe Michigan
United States Forbes Hospital Monroeville Pennsylvania
United States Monticello Cancer Center Monticello Minnesota
United States UPMC-Coraopolis/Heritage Valley Radiation Oncology Moon Pennsylvania
United States Franciscan Health Mooresville Mooresville Indiana
United States Lake Norman Hematology Oncology Specialists-Mooresville Mooresville North Carolina
United States West Virginia University Healthcare Morgantown West Virginia
United States Morristown Medical Center Morristown New Jersey
United States Virtua Memorial Mount Holly New Jersey
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States Skagit Valley Hospital Mount Vernon Washington
United States Skagit Valley Hospital Regional Cancer Care Center Mount Vernon Washington
United States El Camino Hospital Mountain View California
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States Intermountain Medical Center Murray Utah
United States Saint Alphonsus Medical Center-Nampa Nampa Idaho
United States Saint Luke's Mountain States Tumor Institute - Nampa Nampa Idaho
United States Saint Joseph Hospital Nashua New Hampshire
United States Meharry Medical College Nashville Tennessee
United States MD Anderson Regional Care Center-Bay Area Nassau Bay Texas
United States The Hospital of Central Connecticut New Britain Connecticut
United States Saint Peter's University Hospital New Brunswick New Jersey
United States Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut
United States Yale University New Haven Connecticut
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Louisiana State University Health Science Center New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mount Sinai Hospital New York New York
United States Mount Sinai Union Square New York New York
United States Mount Sinai West New York New York
United States Weill Medical College of Cornell University New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Christiana Gynecologic Oncology LLC Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Regional Hematology and Oncology PA Newark Delaware
United States Providence Newberg Medical Center Newberg Oregon
United States Chancellor Center for Oncology Newburgh Indiana
United States USC Norris Oncology/Hematology-Newport Beach Newport Beach California
United States Cancer Center of Kansas - Newton Newton Kansas
United States Illinois Cancer Specialists-Niles Niles Illinois
United States Lakeland Hospital Niles Niles Michigan
United States Sentara Leigh Hospital Norfolk Virginia
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
United States Norwalk Hospital Norwalk Connecticut
United States Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
United States Sutter Cancer Research Consortium Novato California
United States Henry Ford Medical Center-Columbus Novi Michigan
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute Oakland California
United States Hematology and Oncology Associates-Oakland Oakland California
United States Highland General Hospital Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States McKay-Dee Hospital Center Ogden Utah
United States Integris Cancer Institute of Oklahoma Oklahoma City Oklahoma
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Medical Center Olathe Kansas
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Hematology and Oncology Consultants PC Omaha Nebraska
United States Nebraska Medicine-Village Pointe Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Memorial GYN Plus Ooltewah Tennessee
United States Saint Joseph Hospital - Orange Orange California
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States 21st Century Oncology-Orange Park Orange Park Florida
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States Florida Hospital East Orlando Orlando Florida
United States Florida Hospital Orlando Orlando Florida
United States Florida Urology Associates-Orlando Orlando Florida
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Radiation Oncology of Northern Illinois Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Baptist Health Paducah Paducah Kentucky
United States Hope Cancer Care of Nevada-Pahrump Pahrump Nevada
United States 21st Century Oncology-Palatka Palatka Florida
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Midlands Community Hospital Papillion Nebraska
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States Parker Adventist Hospital Parker Colorado
United States Rocky Mountain Cancer Centers-Parker Parker Colorado
United States Camden Clark Medical Center Parkersburg West Virginia
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Keck Medical Center of USC Pasadena Pasadena California
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Memorial Hospital West Pembroke Pines Florida
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Drexel University School of Medicine Philadelphia Pennsylvania
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Temple University Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Mayo Clinic Hospital Phoenix Arizona
United States Via Christi Hospital-Pittsburg Pittsburg Kansas
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC Jefferson Regional Radiation Oncology Pittsburgh Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States UPMC-Passavant Hospital Pittsburgh Pennsylvania
United States UPMC-Presbyterian Hospital Pittsburgh Pennsylvania
United States UPMC-Saint Clair Hospital Cancer Center Pittsburgh Pennsylvania
United States UPMC-Saint Margaret Pittsburgh Pennsylvania
United States UPMC-Shadyside Hospital Pittsburgh Pennsylvania
United States Berkshire Hematology Oncology PC Pittsfield Massachusetts
United States UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida
United States Valley Medical Oncology Consultants Pleasanton California
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Huron Medical Center PC Port Huron Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Kaiser Permanente Northwest Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Cancer Center Post Falls Idaho
United States Pottstown Hospital Pottstown Pennsylvania
United States Vassar Brothers Medical Center Poughkeepsie New York
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Peninsula Cancer Center Poulsbo Washington
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Illinois CancerCare-Princeton Princeton Illinois
United States Utah Valley Regional Medical Center Provo Utah
United States Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Tacoma/Valley Radiation Oncology Centers-Puyallup Puyallup Washington
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Saint Charles Health System-Redmond Redmond Oregon
United States Kaiser Permanente-Redwood City Redwood City California
United States Beebe Health Campus Rehoboth Beach Delaware
United States Alpine Hematology-Oncology Reno Nevada
United States Cancer Care Specialists - Reno Reno Nevada
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Valley Medical Center Renton Washington
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Vidant Oncology-Richlands Richlands North Carolina
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Kaiser Permanente-Riverside Riverside California
United States Riverton Hospital Riverton Utah
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Rochester New York
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States Swedish American Hospital Rockford Illinois
United States SwedishAmerican Regional Cancer Center/ACT Rockford Illinois
United States Memorial Sloan Kettering Rockville Centre Rockville Centre New York
United States Highlands Oncology Group-Rogers Rogers Arkansas
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Kaiser Permanente-Roseville Roseville California
United States Michigan Cancer Specialists Roseville Michigan
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States Cancer Care Associates PC Royal Oak Michigan
United States Comprehensive Medical Center PLLC Royal Oak Michigan
United States Hematology Oncology Consultants PC Royal Oak Michigan
United States Oakland Colon and Rectal Association Royal Oak Michigan
United States Oakland Medical Group Royal Oak Michigan
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente Downtown Commons Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Saint Mary's of Michigan Saginaw Michigan
United States Integrated Community Oncology Network-Flager Cancer Center Saint Augustine Florida
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Saint Cloud Hospital Saint Cloud Minnesota
United States Dixie Medical Center Regional Cancer Center Saint George Utah
United States Saint Helena Hospital Saint Helena California
United States Norris Cotton Cancer Center-North Saint Johnsbury Vermont
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Saint Joseph Oncology Inc Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salina Regional Health Center Salina Kansas
United States Carolina Oncology Associates PA Salisbury North Carolina
United States Peninsula Regional Medical Center Salisbury Maryland
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Kaiser Permanente-San Diego Mission San Diego California
United States Kaiser Permanente-San Diego Zion San Diego California
United States Naval Medical Center -San Diego San Diego California
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Kaiser Permanente-San Francisco San Francisco California
United States UCSF Medical Center-Mission Bay San Francisco California
United States UCSF Medical Center-Mount Zion San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Marcos San Marcos California
United States Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo California
United States Kaiser Permanente-San Rafael San Rafael California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Sutter Pacific Medical Foundation Santa Rosa California
United States Low Country Cancer Care Associates PC Savannah Georgia
United States Memorial Health University Medical Center Savannah Georgia
United States Summit Cancer Care-Memorial Savannah Georgia
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Nanticoke Memorial Hospital Seaford Delaware
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Kaiser Permanente Washington Seattle Washington
United States Minor and James Medical PLLC Seattle Washington
United States Pacific Gynecology Specialists Seattle Washington
United States Seattle Cancer Care Alliance Seattle Washington
United States Seattle Cancer Care Alliance at Northwest Hospital Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-Cherry Hill Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Greenville Health System Cancer Institute-Seneca Seneca South Carolina
United States UPMC Cancer Center at UPMC Northwest Seneca Pennsylvania
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Welch Cancer Center Sheridan Wyoming
United States Dayton Physicians LLC-Wilson Sidney Ohio
United States Avera Cancer Institute Sioux Falls South Dakota
United States Hematology Oncology Associates of Illinois - Skokie Skokie Illinois
United States Memorial Sloan Kettering Sleepy Hollow Sleepy Hollow New York
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States VCU Community Memorial Health Center South Hill Virginia
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth Massachusetts
United States Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Cancer Care Northwest-North Spokane Spokane Washington
United States Cancer Care Northwest-Valley Spokane Washington
United States Evergreen Hematology and Oncology PS Spokane Washington
United States Rockwood Cancer Treatment Center-DHEC-Downtown Spokane Washington
United States Rockwood North Cancer Treatment Center Spokane Washington
United States Spokane Valley Cancer Center-Mayfair Spokane Washington
United States Spokane Valley Cancer Center-Mission Spokane Washington
United States Rockwood Clinic Cancer Treatment Center-Valley Spokane Valley Washington
United States Baystate Medical Center Springfield Massachusetts
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Mercy Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Mitchell Folbe MD PC Sterling Heights Michigan
United States Premier Hematology Oncology Care Sterling Heights Michigan
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Marshfield Clinic Stevens Point Center Stevens Point Wisconsin
United States Saint Michael's Hospital Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Stony Brook University Medical Center Stony Brook New York
United States Houston Methodist Sugar Land Hospital Sugar Land Texas
United States MD Anderson Regional Care Center-Sugar Land Sugar Land Texas
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Overlook Hospital Summit New Jersey
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Cancer Care Specialists of Illinois-Swansea Swansea Illinois
United States Southwest Illinois Health Services LLP Swansea Illinois
United States ProMedica Flower Hospital Sylvania Ohio
United States Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States Tacoma/Valley Radiation Oncology Centers-Jackson Hall Tacoma Washington
United States Tacoma/Valley Radiation Oncology Centers-Saint Joe's Tacoma Washington
United States Tampa General Hospital Tampa Florida
United States Saint Joseph Health System-Tawas City Tawas City Michigan
United States Scott and White Memorial Hospital Temple Texas
United States Union Hospital Terre Haute Indiana
United States MD Anderson Regional Care Center-The Woodlands The Woodlands Texas
United States Lewis Hall Singletary Oncology Center Thomasville Georgia
United States National Jewish Health-Northern Hematology Oncology Thornton Colorado
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States Saint Francis Hospital and Medical Center - Topeka Topeka Kansas
United States Claudia BR Herke MD PC Troy Michigan
United States Dayton Physicians LLC-Upper Valley Troy Ohio
United States Hematology Oncology Consultants PC-Troy Troy Michigan
United States Michigan Institute of Urology-Town Center Troy Michigan
United States Upper Valley Medical Center Troy Ohio
United States William Beaumont Hospital - Troy Troy Michigan
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States The University of Arizona Medical Center-University Campus Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona
United States Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls Idaho
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States UPMC Uniontown Hospital Radiation Oncology Uniontown Pennsylvania
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
* Note: There are 1073 locations in all - only the first 1000 are shown.

Sponsors (3)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology Canadian Cancer Trials Group, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pelvic R0 Resection Rate Number of Participants with Pelvic R0 Resection Up to 5 years
Primary DFS Disease-free Survival (DFS): The distribution of DFS by group will be estimated using the method of Kaplan-Meier. 5 year disease free rates by treatment group with confidence intervals based on Kaplan-Meier curves will be reported. Log-rank test will be used to compare DFS between two treatment groups. Hazard ratio with confidence interval will be estimated based on Cox proportional hazard model. The Cox proportional hazard model will be used for multivariate analysis. Up to 5 years
Secondary Pathologic Complete Response Pathologic Complete Response (pCR): The pCR rate is defined as number of patients who achieve pCR divided by total number of patients included in the analysis population (see definition in Section 16.3.3.1) in each group. Patients who didn't undergo surgery will be classified as non-pCR. Point estimate and confidence interval (according to approach of Duffy and Santner) will be calculated by treatment groups. Chi-square test will be used to compare the pCR rates between groups. Up to 8 years
Secondary Overall Survival Overall Survival (OS): OS is defined as time from randomization to the date of death due to all causes. The distribution of OS by group will be estimated using the method of Kaplan-Meier. Five year survival rates by treatment group with confidence intervals based on Kaplan-Meier curves will be reported. Logrank test will be used to compare OS between two treatment groups. Hazard ratio with confidence interval will be estimated based on Cox proportional hazard model. The Cox proportional hazard model will be used for multivariate analysis. Up to 5 years
Secondary Rates of Receiving Pre- or Post-operative 5FUCMT Rates of Receiving 5FUCMT: For selective group patients, the proportion of patients who received 1) pre-operative 5FUCMT, 2) post-operative 5FUCMT, 3) either pre or post-operative 5FUCMT, and confidence intervals (according to approach of Duffy and Santner) will be reported. Up to 5 years
Secondary Local Recurrence (TLR): Time to Local Recurrence (TLR): The distribution of TLR by group will be estimated using the method of Kaplan-Meier. 5 year local recurrence free rates by treatment group with confidence intervals based on Kaplan-Meier curves will be reported. The comparison of the cumulative incidence of local recurrence between groups, treating distant recurrence and death as competing risks using the test of Gray (Annals of Statistics, 1988) will be conducted. Up to 5 years
Secondary Neoadjuvant Rectal Score neoadjuvant rectal (NAR) score =[5 * pN - 3(cT - pT) + 12]^2/9.61. cT is an element of the set {1, 2, 3, 4}, pT is in {0, 1, 2, 3, 4}, and pN is in {0, 1, 2}. cT clinical tumor stage, pT pathologic tumor stage, pN pathologic nodal stage. Low (NAR <8), intermediate (NAR = 8-16), and high (NAR >16). Low is better and high is worse. Up to 5 years
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