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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00303628
Other study ID # E5204
Secondary ID NCI-2009-00563CD
Status Terminated
Phase Phase 3
First received
Last updated
Start date May 11, 2006
Est. completion date February 11, 2019

Study information

Verified date June 2023
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This randomized phase III trial is studying combination chemotherapy to see how well it works with or without bevacizumab in treating patients who have had surgery for stage II or stage III rectal cancer.


Description:

PRIMARY OBJECTIVES: I. Compare the overall survival of patients who have undergone prior surgery and neoadjuvant chemoradiotherapy for clinical stage II or III rectal cancer treated with adjuvant oxaliplatin, leucovorin calcium, fluorouracil with vs without bevacizumab. SECONDARY OBJECTIVES: I. Evaluate tolerance of treatment, patterns of failure, and disease-free survival in patients treated with these regimens EXPLORATORY OBJECTIVES: I. Assess long-term rectal function using the Patient Bowel Function/Uniscale questionnaire and the Functional Assessment of Cancer (FACT)-Diarrhea subscale in patients treated with these regimens. II. Validate the FACT-Diarrhea subscale. III. Assess long-term symptoms of oxaliplatin-related neurotoxicity using the FACT/Gynecologic Oncology Group (GOG)-Neurotoxicity subscale in patients treated with these regimens. IV. Correlate TS, DPD and TP expression (key targets for fluorouracil); retention of chromosome 18q alleles and microsatellite instability (MSI) with TGFβ1RII mutation (markers for fluorouracil efficacy); ERCC1, ERCC2, and XPF expression (participants in repair of adducts from oxaliplatin); and p53 gene mutation and possibly other molecular markers pertinent to vascular endothelial growth factor in tumor tissue specimens with treatment efficacy in these patients. V. Correlate tumor molecular prognostic markers (chromosome 18q allelic loss and MSI) with survival in patients treated with this regimen. OUTLINE: This is a randomized study. Patients are stratified according to Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1), clinical staging (high risk [T3, N+, M0 or T4, any N, M0] vs low risk [T1-2, N+, M0 or T3, N0, M0]), prior pre-operative oxaliplatin (yes vs no), and prior radiotherapy dose (40-50 Gy vs > 50-55.8 Gy). Patients are randomized to 1 of 2 treatment arms in a 1:1 ratio. ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses* in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive bevacizumab** IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I*. [Note: *Patients who received prior neoadjuvant oxaliplatin including patients on protocol NSABP-R-04 receive up to 9 courses of treatment followed by leucovorin calcium IV and fluorouracil IV with (arm II) or without (arm I) bevacizumab for up to 3 courses.] [Note: **Patients no longer receive bevacizumab as of 4/29/2009 when accrual was terminated due to slow accrual for the study)] Patients complete 10-15 minute questionnaires about bowel function at randomization, end of treatment, 12 months post-treatment and then annually to 5 years post-treatment. After completion of study treatment, patients are followed periodically for approximately 10 years. PROJECTED ACCRUAL: 2100 patients


Recruitment information / eligibility

Status Terminated
Enrollment 355
Est. completion date February 11, 2019
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed adenocarcinoma of the rectum meeting 1 of the following clinical (e.g., before neoadjuvant therapy) or pathologic staging criteria: - T3, N+, M0 - T3, N0, M0 - T4, N0, M0 - Any T, N1-2, M0 - T4, N0-2, M0 disease must meet 1 of the following criteria: - Clinically fixed tumor on rectal examination with tumor adherent to the pelvic sidewall or sacrum - Hydronephrosis on Computed Tomography (CT) scan or Intravenous Pyelogram (IVP) - Ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy - Invasion into prostate - Vaginal or uterine involvement - Must have undergone complete tumor resection >= 28 days ago and able to begin treatment by day 56 - Must have undergone concurrent neoadjuvant chemoradiotherapy* - NOTE: *Neoadjuvant chemoradiotherapy received on protocol NSABP-R-04 allowed provided it met these criteria - Must have undergone prior radiotherapy at 40-55.8 Gy** AND received 1 of the following chemotherapy regimens: - Continuous infusion of fluorouracil with or without oxaliplatin; fluorouracil and leucovorin calcium - Capecitabine with or without oxaliplatin; capecitabine with or without oxaliplatin OR a continuous infusion of fluorouracil with or without oxaliplatin received on protocol NSABP-R-04 - NOTE: **Intensity-modulated radiotherapy allowed - ECOG performance status 0-1 - Platelet count >= 100,000/mm^3 - Absolute granulocyte count >= 1,500/mm^3 - Bilirubin normal (unless chronic grade 1 bilirubin elevation due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin) - Alkaline phosphatase (AP) < 2.5 times upper limit of normal (ULN) and aspartate aminotransferase (AST) < 1.5 times ULN - Hepatitis B and C negative (for patients with AP > normal) unless previously vaccinated - Serum creatinine =< 1.5 times ULN - Urine protein:creatinine (UPC) ratio < 1.0 OR urine protein < 1 g on 24-hour urine collection - International Normalized Ratio (INR) =< 1.5 - INR > 1.5 allowed provided patient is on full-dose anticoagulants AND meets all of the following criteria: - In-range INR (i.e., between 2 and 3) on a stable dose of warfarin or low molecular weight heparin - No active bleeding or pathological condition that is associated with a high risk of bleeding - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study treatment - No other previous or concurrent malignancy except nonmelanoma skin cancer, breast cancer in situ, carcinoma in situ of the cervix, or previously treated nonpelvic cancer that has been disease-free for > 5 years - Patients with a history of breast cancer (without evidence of disease) who remain on hormonal therapy for > 5 years are eligible - Patients with a history of hypertension must have blood pressure < 150/90 mm Hg AND be on a stable regimen of antihypertensive therapy - No other prior chemotherapy or pelvic radiotherapy except as neoadjuvant treatment for current diagnosis of rectal cancer - Concurrent participation on protocol NSABP-R-04 allowed Exclusion Criteria: - Pregnant or nursing - Evidence of metastatic disease on the surgical/intraoperative examination - Evidence of metastatic disease confirmed by CT scan, Magnetic resonance imaging (MRI), or ultrasound of the liver or chest CT scan or chest x-ray within the past 6 months - Evidence of tumor outside of the pelvis, including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy - Concurrent major surgery - Active bleeding not related to the primary rectal tumor within the past 6 months - Active inflammatory bowel disease or other serious medical illness which might limit the ability of the patient to receive protocol therapy - Active gastroduodenal ulcer determined by endoscopy - Serious or nonhealing wound, skin ulcer, or bone fracture - Clinically significant peripheral sensory or motor neuropathy >= grade 2 - Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study treatment including, but not limited to, any of the following: - New York Heart Association class III or IV congestive heart failure - Concurrent symptomatic arrhythmia - Transient ischemic attack or cerebrovascular accident - Arterial thromboembolic event, unstable angina, or myocardial infarction within the past 12 months - Significant peripheral vascular disease - Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude study requirements - Significant traumatic injury within the past 28 days - Known allergy to platinum compounds - Prior invasive procedure, including either of the following: - Major surgical procedure or open biopsy within the past 28 days - Core biopsy or other minor procedure, except placement of a vascular access device, within the past 7 days

Study Design


Intervention

Drug:
oxaliplatin
Given IV
fluorouracil
Given IV
leucovorin calcium
Given IV
bevacizumab
Given IV

Locations

Country Name City State
Canada Cross Cancer Institute Edmonton Alberta
Canada CSSS Champlain-Charles Le Moyne Greenfield Park Quebec
Canada Grand River Regional Cancer Centre at Grand River Hospital Kitchener Ontario
Canada London Regional Cancer Program London Ontario
Canada Credit Valley Hospital Mississauga Ontario
Canada Lakeridge Health Oshawa Oshawa Ontario
Canada Ottawa Health Research Institute-General Division Ottawa Ontario
Canada CHUQ - Pavilion Hotel-Dieu de Quebec Quebec City Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John New Brunswick
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Thunder Bay Regional Health Science Centre Thunder Bay Ontario
Canada Saint Michael's Hospital Toronto Ontario
Canada University Health Network-Princess Margaret Hospital Toronto Ontario
Peru Instituto Nacional de Enfermedades Neoplasicas Lima
Puerto Rico I Gonzales Martinez-Oncologic Hospital San Juan
Puerto Rico San Juan City Hospital San Juan
United States Pali Momi Medical Center 'Aiea Hawaii
United States Abington Memorial Hospital Abington Pennsylvania
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Hematology Oncology Associates Albuquerque New Mexico
United States Presbyterian Kaseman Hospital Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital Allentown Pennsylvania
United States Saint Anthony's Health Alton Illinois
United States American Fork Hospital American Fork Utah
United States McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa
United States Providence Alaska Medical Center Anchorage Alaska
United States AnMed Health Hospital Anderson South Carolina
United States Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Hospital District Sixth of Harper County Anthony Kansas
United States Mission Hospital-Memorial Campus Asheville North Carolina
United States University Cancer and Blood Center LLC Athens Georgia
United States Atlanta Regional CCOP Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Saint Joseph's Hospital of Atlanta Atlanta Georgia
United States Auburn Regional Medical Center Auburn Washington
United States Georgia Regents University Augusta Georgia
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States Well Star Cobb Hospital Austell Georgia
United States Franklin Square Hospital Center Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Bronson Battle Creek Battle Creek Michigan
United States Saint Francis Hospital and Health Centers Beech Grove Indiana
United States Mary Rutan Hospital Bellefontaine Ohio
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Sanford Clinic North-Bemidgi Bemidji Minnesota
United States Saint Charles Medical Center-Bend Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Billings Montana
United States Deaconess Medical Center Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies PC Billings Montana
United States Montana Cancer Consortium CCOP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Bismarck Cancer Center Bismarck North Dakota
United States Mid Dakota Clinic Bismarck North Dakota
United States Saint Alexius Medical Center Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Saint Joseph Medical Center Bloomington Illinois
United States Saint Alphonsus Regional Medical Center Boise Idaho
United States Saint Luke's Mountain States Tumor Institute Boise Idaho
United States Eastern Cooperative Oncology Group Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Bozeman Deaconess Hospital Bozeman Montana
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Ocean Medical Center Brick New Jersey
United States Caritas Saint Elizabeth's Medical Center Brighton Massachusetts
United States Albert Einstein College of Medicine Bronx New York
United States Montefiore Medical Center Bronx New York
United States Kings County Hospital Brooklyn New York
United States State University of New York Downstate Medical Center Brooklyn New York
United States University Hospital of Brooklyn Brooklyn New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Roswell Park Cancer Institute Buffalo New York
United States Veterans Affairs Western New York Health Care System-Buffalo Buffalo New York
United States Mills - Peninsula Hospitals Burlingame California
United States Cone Health Alamance Regional Medical Center Burlington North Carolina
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States University of Vermont Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Cooper Hospital University Medical Center Camden New Jersey
United States Aultman Health Foundation Canton Ohio
United States Graham Hospital Association Canton Illinois
United States Mercy Medical Center Canton Ohio
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Missouri Hospital Cape Girardeau Missouri
United States Memorial Hospital Carthage Illinois
United States East Bay Radiation Oncology Center Castro Valley California
United States Eden Hospital Medical Center Castro Valley California
United States Valley Medical Oncology Consultants-Castro Valley Castro Valley California
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Cedar Rapids Oncology Association Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Providence Centralia Hospital Centralia Washington
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Roper Hospital Charleston South Carolina
United States Carolinas Medical Center Charlotte North Carolina
United States Martha Jefferson Hospital Charlottesville Virginia
United States University of Virginia Charlottesville Virginia
United States Hematology and Oncology Associates Chicago Illinois
United States Jesse Brown Veterans Affairs Medical Center Chicago Illinois
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Mercy Hospital and Medical Center Chicago Illinois
United States Mount Sinai Hospital Medical Center Chicago Illinois
United States Northwestern University Chicago Illinois
United States Resurrection Healthcare Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States Swedish Covenant Hospital Chicago Illinois
United States University of Chicago Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States The Christ Hospital Cincinnati Ohio
United States University of Cincinnati Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States North Coast Cancer Care-Clyde Clyde Ohio
United States Memorial Hospital Colorado Springs Colorado Springs Colorado
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio
United States Columbus CCOP Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States Carolinas Medical Center - Northeast Concord North Carolina
United States Mercy Hospital Coon Rapids Minnesota
United States Hematology and Oncology Associates of Rhode Island Inc Cranston Rhode Island
United States Parkland Memorial Hospital Dallas Texas
United States Saint Paul Hospital Dallas Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States Zale Lipshy University Hospital Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Genesis Medical Center - East Campus Davenport Iowa
United States Genesis Medical Center - West Campus Davenport Iowa
United States Dayton CCOP 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 Samaritan North Health Center Dayton Ohio
United States Veteran Affairs Medical Center Dayton Ohio
United States Oakwood Hospital Dearborn Michigan
United States Atlanta VA Medical Center Decatur Georgia
United States Decatur Memorial Hospital Decatur Illinois
United States Dekalb Medical Center Decatur Georgia
United States Grady Memorial Hospital Delaware Ohio
United States Colorado Cancer Research Program CCOP Denver Colorado
United States Exempla Saint Joseph Hospital Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rose Medical Center Denver Colorado
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa Oncology Research Association CCOP 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 Capitol Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Saint John Hospital and Medical Center 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 Good Samaritan Hospital Downers Grove Illinois
United States Essentia Health Duluth Clinic CCOP Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Hematology Oncology Associates of Central New York PC-East Syracuse East Syracuse New York
United States Memorial Hospital at Easton - Shore Regional Cancer Center Easton Maryland
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Sacred Heart Hospital Eau Claire Wisconsin
United States Fairview-Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elkhart General Hospital Elkhart Indiana
United States Aurora Cancer Care-Southern Lakes Elkhorn Wisconsin
United States Union Hospital of Cecil County Elkton Maryland
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States Hematology Oncology Center Incorporated Elyria Ohio
United States Swedish Medical Center Englewood Colorado
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Eureka Hospital Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Saint Francis Hospital Evanston Illinois
United States Exeter Hospital Exeter New Hampshire
United States Sanford Clinic North-Fargo Fargo North Dakota
United States Sanford Medical Center-Fargo Fargo North Dakota
United States Saint Francis Hospital Federal Way Washington
United States Blanchard Valley Hospital Findlay Ohio
United States Simonds-Sinon Regional Cancer Center Fitchburg Massachusetts
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Agnesian Cancer Center Fond Du Lac Wisconsin
United States Front Range Cancer Specialists Fort Collins Colorado
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 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Fremont Memorial Hospital Fremont Ohio
United States Kaiser Permanente, Fremont Fremont California
United States Valley Medical Oncology Consultants-Fremont Fremont California
United States Cancer Care Associates of Fresno Medical Group Inc Fresno California
United States Unity Hospital Fridley Minnesota
United States Saint Jude Medical Center Fullerton California
United States Galesburg Cottage Hospital Galesburg Illinois
United States Illinois CancerCare Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Aurora Cancer Care-Glendale Glendale Wisconsin
United States Glendale Memorial Hospital and Health Center Glendale California
United States Glens Falls Hospital Glens Falls New York
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Wayne Radiation Oncology Goldsboro North Carolina
United States Altru Cancer Center Grand Forks North Dakota
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Grand Rapids Clinical Oncology Program Grand Rapids Michigan
United States Mercy Health Saint Mary's Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Green Bay Wisconsin
United States Marin General Hospital Greenbrae California
United States Greenville Health System Cancer Institute/Greenville CCOP Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Cancer Institute of New Jersey At Hamilton Hamilton New Jersey
United States Virginia Oncology Associates-Hampton Hampton Virginia
United States Rockingham Memorial Hospital Hahn Cancer Center Harrisonburg Virginia
United States Mason District Hospital Havana Illinois
United States Northern Montana Hospital Havre Montana
United States Kaiser Permanente, Hayward Hayward California
United States Saint Rose Hospital Hayward California
United States Saint Peter's Community Hospital Helena Montana
United States Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois
United States Holland Community Hospital Holland Michigan
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Oncare Hawaii Inc-Kuakini Honolulu Hawaii
United States Oncare Hawaii Inc-POB II 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 Tripler Army Medical Center Honolulu Hawaii
United States University of Hawaii Honolulu Hawaii
United States Hopedale Medical Complex - Hospital Hopedale Illinois
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Hematology Oncology Associates of Eastern Idaho Idaho Falls Idaho
United States Cancer Center of Kansas-Independence Independence Kansas
United States Cleveland Clinic Cancer Center Independence Independence Ohio
United States Saint Vincent Hospital and Health Services Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States Mayo Clinic in Florida Jacksonville Florida
United States Mercy Health System Janesville Wisconsin
United States Joliet Oncology-Hematology Associates Limited Joliet Illinois
United States Midwest Center for Hematology Oncology Joliet Illinois
United States Saint Bernards Regional Medical Center 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 Glacier Oncology PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States University of Kansas Medical Center Kansas City Kansas
United States Cheshire Medical Center-Dartmouth-Hitchcock Keene Keene New Hampshire
United States Columbia Basin Hematology and Oncology PLLC Kennewick Washington
United States Cole, Sharon, K. M.D. (UIA Investigator) Kenton Ohio
United States Kettering Medical Center Kettering Ohio
United States Kewanee Hospital Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee
United States Armstrong Center for Medicine and Health Kittanning Pennsylvania
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Community Howard Regional Health Kokomo Indiana
United States Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin
United States IU Health La Porte Hospital La Porte Indiana
United States The Watson Clinic Lakeland Florida
United States Saint Anthony Hospital Lakewood Colorado
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States Nevada Cancer Research Foundation CCOP Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Gwinnett Medical Center Lawrenceville Georgia
United States Beebe Medical Center Lewes Delaware
United States Saint Mary's Regional Medical Center Lewiston Maine
United States North Shore Hematology Oncology Libertyville Illinois
United States Lima Memorial Hospital Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Meeker County Memorial Hospital Litchfield Minnesota
United States Saint Mary Mercy Hospital Livonia Michigan
United States Logan Regional Hospital Logan Utah
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 University of Southern California/Norris Cancer Center Los Angeles California
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States McKee Medical Center Loveland Colorado
United States Texas Tech University Health Sciences Center Lubbock Texas
United States Lynchburg Hematology-Oncology Clinic Lynchburg Virginia
United States Mcdonough District Hospital Macomb Illinois
United States Medical Center of Central Georgia Macon Georgia
United States Elliot Hospital Manchester New Hampshire
United States Mayo Clinic Health Systems-Mankato Mankato 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 Wellstar Kennestone Hospital Marietta Georgia
United States Bay Area Medical Center Marinette Wisconsin
United States Marquette General Hospital Marquette Michigan
United States Marshfield Clinic Marshfield Wisconsin
United States Saint Joseph's Hospital Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Fremont - Rideout Cancer Center Marysville California
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Saint Luke's Hospital Maumee Ohio
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Maumee Ohio
United States Loyola University Medical Center Maywood Illinois
United States Riddle Hospital Media Pennsylvania
United States University of Tennessee - Memphis Memphis Tennessee
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Mount Sinai Medical Center CCOP Miami Beach Florida
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Orange Regional Medical Center Middletown New York
United States Medical Consultants Limited Milwaukee Wisconsin
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Minneapolis Veterans Medical Center Minneapolis Minnesota
United States Virginia Piper Cancer Institute Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Providence Hospital Mobile Alabama
United States Garneau, Stewart C MD (UIA Investigator) Moline Illinois
United States Porubcin, Michael MD (UIA Investigator) Moline Illinois
United States Sharis, Christine M MD (UIA Investigator) Moline Illinois
United States Stoffel, Thomas J MD (UIA Investigator) Moline Illinois
United States Vigliotti, Antonio, P.G. M.D. (UIA Investigator) Moline Illinois
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital Monroe Michigan
United States Mountainside Hospital Montclair New Jersey
United States Community Hospital of Monterey Peninsula Monterey California
United States Morristown Memorial Hospital Morristown New Jersey
United States Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Mount Holly New Jersey
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States El Camino Hospital Mountain View California
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States IU Health Ball Memorial Hospital Muncie Indiana
United States Cottonwood Hospital Medical Center Murray Utah
United States Intermountain Medical Center Murray Utah
United States Mercy Health Mercy Campus Muskegon Michigan
United States Mercy Health Partners-Hackley Campus Muskegon Michigan
United States Edward Hospital/Cancer Center Naperville Illinois
United States Meharry Medical College Nashville Tennessee
United States Nashville Oncology Associates PC Nashville Tennessee
United States Tennessee Oncology PLLC- Centennial Medical Center Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Columbia University Medical Center New York New York
United States New York University Langone Medical Center 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 Licking Memorial Hospital Newark Ohio
United States Newark Beth Israel Medical Center Newark New Jersey
United States Oncology Hematology Associates of Southwest Indiana Newburgh Indiana
United States Cancer Center of Kansas - Newton Newton Kansas
United States Illinois Cancer Specialists-Niles Niles Illinois
United States Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Southwest VA Regional Cancer Center Norton Virginia
United States Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
United States Sutter Cancer Research Consortium Novato California
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Breast Surgeons Inc Oakland California
United States Bay Area Tumor Institute CCOP Oakland California
United States Highland General Hospital Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States Larry G Strieff MD Medical Corporation Oakland California
United States Tom K Lee Inc Oakland California
United States Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin
United States McKay-Dee Hospital Center Ogden Utah
United States Cancer Care Associates Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Cancer Center Olathe Kansas
United States Providence - Saint Peter Hospital Olympia Washington
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Missouri Valley Cancer Consortium CCOP Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Cancer Specialists of North Florida-Orange Park Orange Park Florida
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Desert Regional Medical Center Palm Springs California
United States Palo Alto Medical Foundation Heath Care Palo Alto California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Camden-Clark Memorial Hospital Parkersburg West Virginia
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Pekin Cancer Treatment Center Pekin Illinois
United States Pekin Hospital Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois Oncology Research Association CCOP 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 Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois Valley Hospital Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Albert Einstein Medical Center Philadelphia Pennsylvania
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Pennsylvania Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States Allegheny Cancer Center at Allegheny General Hospital Pittsburgh Pennsylvania
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Berkshire Hematology Oncology PC Pittsfield Massachusetts
United States Valley Care Health System - Pleasanton Pleasanton California
United States Valley Medical Oncology Consultants Pleasanton California
United States Portneuf Medical Center Pocatello Idaho
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Saint Joseph Mercy Port Huron Port Huron Michigan
United States Adventist Medical Center Portland Oregon
United States Kaiser Permanente Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Western Oncology Research Consortium Portland Oregon
United States Pottstown Memorial Medical Center Pottstown Pennsylvania
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Perry Memorial Hospital Princeton Illinois
United States Utah Valley Regional Medical Center Provo Utah
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Good Samaritan Community Hospital Puyallup Washington
United States Kaiser Permanente-Redwood City Redwood City California
United States Marshfield Clinic at James Beck Cancer Center Rhinelander Wisconsin
United States Marshfield Clinic-Rice Lake Center Rice Lake Wisconsin
United States Kaiser Permanente-Richmond Richmond California
United States Reid Hospital and Health Care Services Richmond Indiana
United States Valley Hospital Ridgewood New Jersey
United States Southern Regional Medical Center Riverdale Georgia
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Highland Hospital Rochester New York
United States Interlakes Foundation Inc-Rochester Rochester New York
United States Mayo Clinic Rochester Minnesota
United States University of Rochester Rochester New York
United States Swedish American Hospital Rockford Illinois
United States Harbin Clinic Medical Oncology and Clinical Research Rome Georgia
United States Kaiser Permanente-Roseville Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Rutherford Hospital Rutherfordton North Carolina
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States University of California at Davis Cancer Center Sacramento California
United States Saint Mary's of Michigan Saginaw Michigan
United States Dixie Medical Center Regional Cancer Center Saint George Utah
United States Lakeland Hospital Saint Joseph Michigan
United States Center for Cancer Care and Research Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint John's Mercy Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Saint Louis University Hospital Saint Louis Missouri
United States Saint Louis-Cape Girardeau CCOP Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Metro-Minnesota CCOP Saint Louis Park Minnesota
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States Saint Joseph's Hospital - Healtheast Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salinas Valley Memorial Salinas California
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Intermountain Health Care 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 California
United States University of California At San Diego San Diego California
United States California Pacific Medical Center San Francisco California
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose 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 Firelands Regional Medical Center Sandusky Ohio
United States North Coast Cancer Care Sandusky Ohio
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States New Mexico Cancer Care Associates Santa Fe New Mexico
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Memorial Health University Medical Center Savannah Georgia
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Hematology and Oncology Associates of North East Pennsylvania Scranton Pennsylvania
United States Mercy Hospital Scranton Pennsylvania
United States Scranton Hematology Oncology Scranton Pennsylvania
United States Group Health Cooperative-Seattle Seattle Washington
United States Minor and James Medical PLLC Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States The Polyclinic Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Welch Cancer Center Sheridan Wyoming
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Hematology Oncology Associates Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Medical X-Ray Center Sioux Falls South Dakota
United States Sanford Cancer Center-Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Edward H Kaplan MD and Associates Skokie Illinois
United States Hematology Oncology Associates of Illinois - Skokie Skokie Illinois
United States Midwest Cancer Research Group Incorporated Skokie Illinois
United States Memorial Hospital of South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Sparta Cancer Treatment Center Sparta New Jersey
United States Spartanburg Regional Medical Center Spartanburg South Carolina
United States Upstate Carolina CCOP Spartanburg South Carolina
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Rockwood Clinic Spokane Washington
United States Saint Margaret's Hospital Spring Valley Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Springfield Regional Medical Center Springfield Ohio
United States Geisinger Medical Group State College Pennsylvania
United States Saint Michael's Hospital Stevens Point Wisconsin
United States Kaiser Permanente-Stockton Stockton California
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Overlook Hospital Summit New Jersey
United States Flower Hospital Sylvania Ohio
United States Community General Hospital Syracuse New York
United States State University of New York Upstate Medical University Syracuse New York
United States Allenmore Hospital Tacoma Washington
United States Madigan Army Medical Center Tacoma Washington
United States Multicare Health System Tacoma Washington
United States Northwest CCOP Tacoma Washington
United States Saint Clare Hospital Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States Scott and White Memorial Hospital Temple Texas
United States North Suburban Medical Center Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Saint Anne Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States Stark, Michael, Edward. M.D. (UIA Investigator) Toledo Ohio
United States The Toledo Hospital/Toledo Children's Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States Stormont-Vail Regional Health Center Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States Upper Valley Medical Center Troy Ohio
United States Tahoe Forest Cancer Center Truckee California
United States Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma
United States Carle Cancer Center Urbana Illinois
United States Carle Clinic-Urbana Main Urbana Illinois
United States Kaiser Permanente-Vallejo Vallejo California
United States Sutter Solano Medical Center Vallejo California
United States Compass Oncology Vancouver Vancouver Washington
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Virtua West Jersey Hospital Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States Maui Memorial Medical Center Wailuku Hawaii
United States Pacific Cancer Institute of Maui Wailuku Hawaii
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Kent County Hospital Warwick Rhode Island
United States Lombardi Comprehensive Cancer Center at Georgetown University Washington District of Columbia
United States Washington Hospital Center Washington District of Columbia
United States Cedar Valley Medical Specialists Waterloo Iowa
United States Covenant Medical Center Waterloo Iowa
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Main Office Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Via Christi Regional Medical Center Wichita Kansas
United States Wichita CCOP Wichita Kansas
United States Geisinger Wyoming Valley Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Clinton Memorial Hospital Wilmington Ohio
United States Wilson Medical Center Wilson North Carolina
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology and Hematology PA-Woodbury Woodbury Minnesota
United States Woodwinds Health Campus Woodbury Minnesota
United States Cleveland Clinic Wooster Specialty Center Wooster Ohio
United States University of Massachusetts Medical School Worcester Massachusetts
United States Lankenau Hospital Wynnewood Pennsylvania
United States Mainline Health CCOP Wynnewood Pennsylvania
United States Metro Health Hospital Wyoming Michigan
United States Greene Memorial Hospital Xenia Ohio
United States WellSpan Health-York Hospital York Pennsylvania
United States Genesis HealthCare System Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Peru,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Rectal Function Between Baseline and 12 Months Change in rectal function between baseline and 12 months was measuring the long-term rectal function among the patients. Rectal function was measured using the Bowel Function Questionnaire at baseline and 12 months after randomization. The total score of the questionnaire was calculated as the number of problems with bowel function (score range 0-11). Change in rectal function between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated improved rectal function. This change in score was calculated for each individual patient who had the data. assessed at baseline and 12 months after randomization
Other Change in Oxaliplatin-related Neurotoxicity Between Baseline and 12 Months Change in oxaliplatin-related neurotoxicity between baseline and 12 months was measuring the long-term symptom of oxaliplatin-related neurotoxicity among the patients. Oxaliplatin-related neurotoxicity was measured using the FACT/GOG-Ntx subscale at baseline and 12 months after randomization. The range of the total score of the scale was between 0 and 44, and lower values indicate higher neurotoxicity. Change in oxaliplatin-related neurotoxicity between baseline and 12 months= total score at 12 months - total score at baseline. A negative value indicated worsened symptom. This change in score was calculated for each individual patient who had the data. assessed at baseline and 12 months after randomization
Primary 5-year Overall Survival Rate Overall survival (OS) was defined as time from randomization to date of death from any cause. Patients who were still alive were censored at last date of known alive. Kaplan-Meier method was used to estimate the 5-year OS rate. Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization
Secondary 5-year Disease-free Survival Rate Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer or death, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Kaplan-Meier method was used to estimate 5-year DFS rate. Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization
Secondary Patterns of Failure Failure included recurrence, second primary cancer and death without recurrence. Follow-up assessments performed every 3 months for patients < 2 years from randomization, every 6 months for patients 2-5 years from randomization, and every 12 months for patients 5-10 years from randomization
Secondary Proportion of Patients Who Completed 12 Cycles of Treatment In the study, treatment was repeated every 2 weeks for a total of 12 cycles on both arms. The total number of cycles of treatment patient received until going off treatment due to any reason was recorded. It was a measure of the tolerance of the therapy. assessed at the end of treatment
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