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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00041119
Other study ID # CALGB-40101
Secondary ID CDR0000069444NCI
Status Active, not recruiting
Phase Phase 3
First received July 8, 2002
Last updated August 11, 2016
Start date May 2002

Study information

Verified date August 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer


Description:

PRIMARY OBJECTIVES:

I. To determine the equivalence of paclitaxel given every two weeks with cyclophosphamide and doxorubicin hydrochloride (CA) given every two weeks as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival.

II. To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for disease-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes.

SECONDARY OBJECTIVES:

I. To determine the equivalence of paclitaxel given every two weeks with CA given every two weeks, and the potential superiority of longer vs. shorter therapy, in relation to overall survival, local control (regardless of metastatic status) and time to distant metastases (regardless of local recurrence status).

II. To compare toxicities of short and long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer.

III. To determine the effect of long and short course CA and paclitaxel on the induction of menopause for pre-menopausal patients.

IV. To assess the discrepancy of myelosuppression among the common multidrug resistance protein 1 (MDR1) haplotypes in the CA treatment arm.

V. To assess the effect of MDR1 haplotypes on disease-free survival (DFS) adjusted for treatment.

VI. Exploratory analysis of the effect of cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A5), cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8), and cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6) polymorphisms on DFS and toxicity.

VII. To identify genetic markers associated with the risk of developing neutropenia in adriamycin/ cyclophosphamide-treated breast cancer patients.

VIII. To identify genetic markers associated with the risk of developing peripheral neuropathy in paclitaxel-treated breast cancer patients.

IX. To identify genetic markers associated with differences in the efficacy of each chemotherapy regimen.

X. To examine genetic associations with other response and toxicity phenotypes that become apparent during future analysis of Cancer and Leukemia Group B (CALGB) 40101 data.

XI. To identify copy number variants associated with adriamycin/cyclophosphamide-induced neutropenia and paclitaxel-induced peripheral neuropathy.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive cyclophosphamide intravenously (IV) and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM IV: Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Note: Randomization to Arms II and IV is no longer available, effective 12/15/2007.

After completion of study treatment patients are followed up for 4-6 weeks, every 6 months for 2 years, and then annually for up to 13 years.


Other known NCT identifiers
  • NCT00698217

Recruitment information / eligibility

Status Active, not recruiting
Enrollment 4646
Est. completion date
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Eligibility Criteria:

- Patients must have histologically confirmed invasive carcinoma of the female breast, with 0-3 positive axillary lymph nodes

- Patients must have 0-3 positive axillary lymph nodes to be eligible for this study; patients with node-negative breast cancer should have sufficiently "high risk" disease to warrant chemotherapy; as general guidelines, node-negative patients with tumors of >= 1 cm or estrogen or progesterone receptor negative tumors of any size may be eligible; ultimately though, the definition of "high risk" may be determined by the treating physician, and if the treating physician feels the patient warrants chemotherapy, the patient is eligible; for patients with 1-3 positive axillary nodes, the patient is eligible regardless of primary breast tumor characteristics, if in the opinion of the treating physician, chemotherapy is deemed potentially beneficial to the patient

- If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative; if an axillary dissection, without a sentinel node biopsy, is performed to determine nodal status, at least six axillary lymph nodes must be removed and analyzed and negative for the patient to be considered node-negative; axillary nodes with single cells or tumor clusters =< 0.2 mm by either hematoxylin and eosin stain (H&E) or immunohistochemistry (IHC), will be considered node-negative; lymph nodes positive for polymerase chain reaction (PCR) with tumor cells/clusters =< 0.2 mm will be considered node-negative; any axillary lymph node with tumor clusters > 0.2 mm will be considered positive

- If the patient has a sentinel node biopsy and one of the sentinel nodes is positive, as defined by tumor clusters > 0.2 mm, an axillary dissection must be performed; a total of at least 6 axillary lymph nodes, including sentinel nodes plus the subsequent dissection, must be removed for the patient to be eligible; of all the lymph nodes removed from both the sentinel node procedure and the axillary dissection, 1-3 must be positive for the patient to be eligible as a node-positive patient; if an axillary dissection is done without a sentinel node procedure, at least 6 lymph nodes must be removed and a 1-3 nodes must be positive for the patient to be considered node-positive and eligible for this study

- Determination of involvement of axillary nodes with metastatic cancer will follow the revised tumor-node-metastasis (TNM) staging system: axillary nodes with single cells with tumor clusters =< 0.2 mm, by either H&E or immunohistochemistry (IHC), will be considered negative axillary node; lymph nodes positive for PCR with tumor cells/clusters < 0.2 mm will be considered negative axillary node; any axillary lymph node with clusters > 0.2 mm will be considered to be positive

- Patients with estrogen-receptor and/or progesterone receptor negative, positive, or unknown tumors are eligible; estrogen-receptor (ER) and progesterone receptor (PgR) assays should be performed by immunohistochemical methods according to the local institution's standard protocol

- Patients with human epidermal growth factor receptor 2 (HER2) positive, negative or unknown disease are eligible for this trial; patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or demonstrate gene amplification by fluorescence in situ hybridization (FISH) may receive trastuzumab

- There must be negative tumor margins for invasive cancer and ductal carcinoma in situ (DCIS) in the case of mastectomy or lumpectomy; lobular carcinoma in situ (LCIS) is acceptable at the margin

- Patients with multi-centric breast cancer are eligible as long as all known disease is resected with negative margins, and have 0-3 positive axillary lymph nodes

- Patients must be registered within 84 days of the last breast surgery; patients must have undergone either modified radical mastectomy or lumpectomy; for patients undergoing sentinel node sampling or axillary dissection a simple mastectomy is acceptable; lumpectomy patients must receive radiation therapy; for patients treated with radiation therapy prior to chemotherapy, the patients should be registered on this study after the conclusion of radiation, with chemotherapy administration beginning within 7 days of registration

* All primary breast and axillary node surgery must be completed prior to enrollment on study

- No previous trastuzumab, chemotherapy or hormonal therapy for this malignancy, except for tamoxifen therapy

- No previous anthracycline chemotherapy for any disease

- Patients with locally advanced breast cancer, inflammatory breast cancer or metastatic breast cancer are not eligible; patients with involvement of dermal lymphatics on pathology are not eligible, even if there are no clinical signs of inflammatory cancer

- Patients with bilateral, synchronous invasive breast cancer are eligible as long as both primary tumors; if a patient has an invasive cancer on one side that meets the eligibility criteria, and DCIS or LCIS on the contralateral side, the patient is eligible; DCIS or LCIS should be managed according to institutional guidelines

- Patients must be disease free from prior malignancies for > 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix; patients with a history of invasive breast cancer, or DCIS are eligible if they have been disease free for > 5 years; patients with a history of LCIS are eligible regardless of the interval from diagnosis

- Common Toxicity Criteria (CTC) performance status 0-1

- Women must not be pregnant or nursing

- Concomitant exogenous hormone therapy, including oral contraceptives, post-menopausal hormone replacement therapy, and raloxifene must be stopped before patients can be enrolled

- Patients may have received up to 4 weeks of tamoxifen therapy for this malignancy and still be eligible for this study; patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for prevention or for other indicators (e.g. osteoporosis) are eligible; tamoxifen therapy or other SERMs must be discontinued before the patient is enrolled on this study

* The use of bisphosphonates for the treatment of osteoporosis is permitted; the use of raloxifene is not permitted are enrollment on this study

- Patients must have adequate organ function including no active congestive heart failure, and no myocardial infarction < 6 months from time of registration

- Absolute neutrophil count (ANC) >= 1,000/mm^3

- Platelet count >= 100,00/mm^3

- Creatinine =< 2.0 mg/dl

- Bilirubin =< 1.5 x upper limits of institutional normal

- Patients may be enrolled on adjuvant bisphosphonate studies; patients may be enrolled concurrently or sequentially on 40101 and bisphosphonate trials

- Patients may be enrolled on adjuvant hormonal studies approved by CALGB or Cancer Trials Support Unit (CTSU), such as the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT) trials

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AC regimen
Given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
paclitaxel
Given IV

Locations

Country Name City State
South Africa Pretoria Academic Hospital Pretoria
United States Oncology Services of Aberdeen Aberdeen South Dakota
United States Hickman Cancer Center at Bixby Medical Center Adrian Michigan
United States Summa Center for Cancer Care at Akron City Hospital Akron Ohio
United States Saint Anthony's Hospital at Saint Anthony's Health Center Alton Illinois
United States Harrington Cancer Center Amarillo Texas
United States McFarland Clinic, PC Ames Iowa
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States Saint Joseph Mercy Cancer Center Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Regional Medical Center Anniston Alabama
United States Randolph Hospital Asheboro North Carolina
United States Cancer Resource Center at King's Daughters Medical Center Ashland Kentucky
United States Sturdy Memorial Hospital Attleboro Massachusetts
United States Auburn Regional Center for Cancer Care Auburn Washington
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Aurora Presbyterian Hospital Aurora Colorado
United States Rush-Copley Cancer Care Center Aurora Illinois
United States Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
United States Barberton Citizens Hospital Barberton Ohio
United States Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge Louisiana
United States Ochsner Health Center - Bluebonnet Baton Rouge Louisiana
United States Pennington Cancer Center at Baton Rouge General Baton Rouge Louisiana
United States St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana
United States St. Joseph Cancer Center Bellingham Washington
United States MeritCare Bemidji Bemidji Minnesota
United States Alta Bates Summit Comprehensive Cancer Center Berkeley California
United States Hematology Oncology Associates of the Quad Cities Bettendorf Iowa
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States UAB Comprehensive Cancer Center Birmingham Alabama
United States Bismarck Cancer Center Bismarck North Dakota
United States Medcenter One Hospital Cancer Care Center Bismarck North Dakota
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States St. Alexius Medical Center Cancer Center Bismarck North Dakota
United States Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise Idaho
United States Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts
United States Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Wood County Oncology Center Bowling Green Ohio
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States Skaggs Cancer Center at Skaggs Regional Medical Center Branson Missouri
United States Olympic Hematology and Oncology Bremerton Washington
United States Caritas St. Elizabeth's Medical Center Brighton Massachusetts
United States Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx New York
United States Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx New York
United States Roswell Park Cancer Institute Buffalo New York
United States Peninsula Medical Center Burlingame California
United States Alamance Cancer Center at Alamance Regional Medical Center Burlington North Carolina
United States Lahey Clinic Medical Center - Burlington Burlington Massachusetts
United States Fairview Ridges Hospital Burnsville Minnesota
United States St. James Healthcare Cancer Care Butte Montana
United States Aultman Cancer Center at Aultman Hospital Canton Ohio
United States Mercy Cancer Center at Mercy Medical Center Canton Ohio
United States Saint Francis Medical Center Cape Girardeau Missouri
United States East Bay Radiation Oncology Center Castro Valley California
United States Valley Medical Oncology Consultants - Castro Valley Castro Valley California
United States Cedar Rapids Oncology Associates Cedar Rapids Iowa
United States Iowa Blood and Cancer Care Cedar Rapids Iowa
United States Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa
United States St. Luke's Hospital Cedar Rapids Iowa
United States Providence Centralia Hospital Centralia Washington
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States Roper St. Francis Cancer Center at Roper Hospital Charleston South Carolina
United States Martha Jefferson Hospital Cancer Care Center Charlottesville Virginia
United States Saint Luke's Hospital Chesterfield Missouri
United States Creticos Cancer Center at Advocate Illinois Masonic Medical Center Chicago Illinois
United States Hematology and Oncology Associates Chicago Illinois
United States Mount Sinai Hospital Medical Center Chicago Illinois
United States Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois
United States Swedish Covenant Hospital Chicago Illinois
United States University of Illinois Cancer Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic - Chippewa Center Chippewa Falls Wisconsin
United States Case Comprehensive Cancer Center Cleveland Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland Ohio
United States North Coast Cancer Care - Clyde Clyde Ohio
United States Memorial Hospital Cancer Center - Colorado Springs Colorado Springs Colorado
United States Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado
United States Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri
United States Palmetto Health South Carolina Cancer Center Columbia South Carolina
United States Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Medical Center Cancer Care Columbus Ohio
United States John B. Amos Cancer Center Columbus Georgia
United States Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States Batte Cancer Center at Northeast Medical Center Concord North Carolina
United States New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord New Hampshire
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States Heartland Oncology and Hematology Council Bluffs Iowa
United States Ochsner Health Center - Covington Covington Louisiana
United States Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas
United States Genesis Regional Cancer Center at Genesis Medical Center Davenport Iowa
United States CCOP - Dayton Dayton Ohio
United States David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Samaritan North Cancer Care Center Dayton Ohio
United States Herbert D. Kerman Regional Oncology Center - Daytona Beach Daytona Beach Florida
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States Decatur Memorial Hospital Cancer Care Institute Decatur Illinois
United States Grady Memorial Hospital Delaware Ohio
United States CCOP - Colorado Cancer Research Program Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - St. Luke's Medical Center Denver Colorado
United States Rose Medical Center Denver Colorado
United States St. Anthony Central Hospital Denver Colorado
United States St. Joseph Hospital Denver Colorado
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Mercy Capitol Hospital Des Moines Iowa
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States CCOP - Duluth Duluth Minnesota
United States Duluth Clinic Cancer Center - Duluth Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States St. Luke's Hospital Cancer Care Center Duluth Minnesota
United States Duke Comprehensive Cancer Center Durham North Carolina
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Luther Midlelfort Hospital Eau Claire Wisconsin
United States Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin
United States Midelfort Clinic - Luther Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Alexian Brothers Radiation Oncology Elk Grove Village Illinois
United States Elkhart Clinic, LLC Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn Elkhorn Wisconsin
United States Union Hospital Cancer Program at Union Hospital Elkton MD Maryland
United States Elmhurst Hospital Center Elmhurst New York
United States Swedish Medical Center Englewood Colorado
United States St. Francis Hospital Evanston Illinois
United States Center for Cancer Care at Exeter Hospital Exeter New Hampshire
United States Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital Fairbanks Alaska
United States Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River Massachusetts
United States CCOP - MeritCare Hospital Fargo North Dakota
United States MeritCare Broadway Fargo North Dakota
United States Cape Fear Valley Medical Center Cancer Center Fayetteville North Carolina
United States St. Francis Hospital Federal Way Washington
United States Fergus Falls Medical Group, PA Fergus Falls Minnesota
United States Blanchard Valley Medical Associates Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Middletown Regional Hospital Franklin Ohio
United States Frederick Memorial Hospital Regional Cancer Therapy Center Frederick Maryland
United States Fredericksburg Oncology, Incorporated Fredericksburg Virginia
United States Valley Medical Oncology Fremont California
United States Washington Township Hospital Fremont California
United States California Cancer Center - Woodward Park Office Fresno California
United States Cancer Care Associates Fresno California
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Ft. Smith Arkansas
United States Northeast Georgia Medical Center Gainesville Georgia
United States University of Florida Shands Cancer Center Gainesville Florida
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Altru Cancer Center at Altru Hospital Grand Forks North Dakota
United States Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center Grand Island Nebraska
United States St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction Colorado
United States Three Rivers Community Hospital Grants Pass Oregon
United States Great Falls Clinic - Main Facility Great Falls Montana
United States Sletten Cancer Institute at Benefis Healthcare Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center Green Bay Wisconsin
United States Marin Cancer Institute at Marin General Hospital Greenbrae California
United States Moses Cone Regional Cancer Center at Wesley Long Community Hospital Greensboro North Carolina
United States CCOP - Greenville Greenville South Carolina
United States Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina
United States Wayne Hospital Greenville Ohio
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Virginia Oncology Associates - Hampton Hampton Virginia
United States Helen and Harry Gray Cancer Center at Hartford Hospital Hartford Connecticut
United States Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut
United States Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey Illinois
United States Hattiesburg Clinic, PA at Forrest General Hattiesburg Mississippi
United States Hematology & Oncology Clinic Hattiesburg Mississippi
United States St. Peter's Hospital Helena Montana
United States Maria Parham Medical Center Henderson North Carolina
United States Pardee Memorial Hospital Hendersonville North Carolina
United States Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania
United States Memorial Cancer Institute at Memorial Regional Hospital Hollywood Florida
United States New Hampshire Oncology - Hematology, PA - Hooksett Hooksett New Hampshire
United States Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Huntington West Virginia
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cape Cod Hospital Hyannis Massachusetts
United States Cancer Center of Kansas-Independence Independence Kansas
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Foote Memorial Hospital Jackson Michigan
United States University of Mississippi Cancer Clinic Jackson Mississippi
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Queens Cancer Center of Queens Hospital Jamaica New York
United States Mercy Regional Cancer Center Janesville Wisconsin
United States UW Cancer Center Johnson Creek Johnson Creek Wisconsin
United States Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois
United States Midwest Center for Hematology/Oncology Joliet Illinois
United States St. John's Regional Medical Center Joplin Missouri
United States Ella Milbank Foshay Cancer Center at 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 Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology at KRMC Kalispell Montana
United States Provena St. Mary's Regional Cancer Center - Kankakee Kankakee Illinois
United States CCOP - Kansas City Kansas City Missouri
United States Heartland Hematology Oncology Associates, Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Parvin Radiation Oncology Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri
United States St. Joseph Medical Center Kansas City Missouri
United States Truman Medical Center - Hospital Hill Kansas City Missouri
United States Good Samaritan Cancer Center at Good Samaritan Hospital Kearney Nebraska
United States Kingsbury Center for Cancer Care at Cheshire Medical Center Keene New Hampshire
United States Columbia Basin Hematology Kennewick Washington
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Kinston Medical Specialists Kinston North Carolina
United States Cascade Cancer Center at Evergreen Hospital Medical Center Kirkland Washington
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Howard Community Hospital Kokomo Indiana
United States Franciscan Skemp Healthcare - La Crosse Campus La Crosse Wisconsin
United States Gundersen Lutheran Center for Cancer and Blood La Crosse Wisconsin
United States Rebecca and John Moores UCSD Cancer Center La Jolla California
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Lakes Region General Hospital Laconia New Hampshire
United States Center for Cancer Care and Research at Watson Clinic, LLP Lakeland Florida
United States Lakeland Regional Cancer Center at Lakeland Regional Medical Center Lakeland Florida
United States Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville Michigan
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster General Hospital Lancaster Pennsylvania
United States Sparrow Regional Cancer Center Lansing Michigan
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Cleo Craig Cancer Research Clinic Lawton Oklahoma
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States Lewistown Hospital Lewistown Pennsylvania
United States Southwest Medical Center Liberal Kansas
United States Lima Memorial Hospital Lima Ohio
United States St. Rita's Medical Center Lima Ohio
United States Cancer Resource Center - Lincoln Lincoln Nebraska
United States St. Mary Mercy Hospital Livonia Michigan
United States Dana-Farber Cancer Institute at Londonderry Londonderry New Hampshire
United States Sky Ridge Medical Center Lone Tree Colorado
United States Hope Cancer Care Center at Longmont United Hospital Longmont Colorado
United States USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California
United States McKee Medical Center Loveland Colorado
United States Lowell General Hospital Lowell Massachusetts
United States Southeastern Regional Medical Center Lumberton North Carolina
United States Lynchburg Hematology-Oncology Clinic Lynchburg Virginia
United States Medical Center of Central Georgia Macon Georgia
United States Dean Medical Center - Madison Madison Wisconsin
United States University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin
United States Elliot Regional Cancer Center at Elliot Hospital Manchester New Hampshire
United States Holy Family Memorial Medical Center Cancer Care Center Manitowoc Wisconsin
United States Immanuel St. Joseph's Mankato Minnesota
United States HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota
United States Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Vince Lombardi Cancer Clinic - Marinette Marinette Wisconsin
United States Marshfield Clinic - Marshfield Center Marshfield Wisconsin
United States Saint Joseph's Hospital Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Tibotec Therapeutics - Division of Ortho Biotech Products, LP Marysville California
United States Northwest Ohio Oncology Center Maumee Ohio
United States St. Luke's Hospital Maumee Ohio
United States Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois
United States Dubs Cancer Center at Rogue Valley Medical Center Medford Oregon
United States Providence Cancer Center at PMCC Medford Oregon
United States Columbia Saint Mary's Hospital - Ozaukee Mequon Wisconsin
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States Saint Anthony Memorial Health Centers Michigan City Indiana
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Columbia-Saint Mary's Cancer Care Center Milwaukee Wisconsin
United States Medical Consultants, Limited Milwaukee Wisconsin
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Hennepin County Medical Center - Minneapolis Minneapolis Minnesota
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Marshfield Clinic - Lakeland Center Minocqua Wisconsin
United States Trinity CancerCare Center Minot North Dakota
United States Community Medical Center Missoula Montana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Providence Cancer Center at Providence Hospital Mobile Alabama
United States Memorial Medical Center Modesto California
United States Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline Illinois
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital - Monroe Monroe Michigan
United States Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown New Jersey
United States Good Samaritan Regional Health Center Mt. Vernon Illinois
United States Skagit Valley Hospital Cancer Care Center Mt. Vernon Washington
United States MBCCOP - Meharry Medical College - Nashville Nashville Tennessee
United States Nashville Oncology Associates, PC Nashville Tennessee
United States CCOP - Ochsner New Orleans Louisiana
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Medical Center of Louisiana - New Orleans New Orleans Louisiana
United States Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana
United States Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai Medical Center New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States UMDNJ University Hospital Newark New Jersey
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States Callahan Cancer Center at Great Plains Regional Medical Center North Platte Nebraska
United States Fisher-Titus Medical Center Norwalk Ohio
United States Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
United States Caritas Norwood Hospital Norwood Massachusetts
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Breast Surgeons, Incorporated Oakland California
United States CCOP - Bay Area Tumor Institute Oakland California
United States Highland General Hospital Oakland California
United States Tom K Lee, Incorporated Oakland California
United States Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Cancer Care Associates - Mercy Campus Oklahoma City Oklahoma
United States Oklahoma University Cancer Institute Oklahoma City Oklahoma
United States Providence St. Peter Hospital Regional Cancer Center Olympia Washington
United States Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields Olympia Fields Illinois
United States Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska
United States CCOP Missouri Valley Cancer Consortium Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Immanuel Medical Center Omaha Nebraska
United States Methodist Estabrook Cancer Center Omaha Nebraska
United States UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska
United States Integrated Community Oncology Network - Orange Park Orange Park Florida
United States St. Charles Mercy Hospital Oregon Ohio
United States Toledo Clinic - Oregon Oregon Ohio
United States Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida
United States Menorah Medical Center Overland Park Kansas
United States Granville Medical Center Oxford North Carolina
United States Advocate Lutheran General Cancer Care Center Park Ridge Illinois
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Regional Cancer Center at Singing River Hospital Pascagoula Mississippi
United States Memorial Hospital of Rhode Island Pawtucket Rhode Island
United States NSMC Cancer Center - Peabody Peabody Massachusetts
United States Northern Michigan Hospital Petoskey Michigan
United States Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania
United States Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia Pennsylvania
United States Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States Allegheny Cancer Center at Allegheny General Hospital Pittsburgh Pennsylvania
United States UPMC Cancer Centers Pittsburgh Pennsylvania
United States Berkshire Hematology Oncology, PC Pittsfield Massachusetts
United States Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center Plattsburgh New York
United States Valley Care Medical Center Pleasanton California
United States Valley Medical Oncology Consultants - Pleasanton Pleasanton California
United States St. Joseph Mercy Oakland Pontiac Michigan
United States Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan
United States Adventist Medical Center Portland Oregon
United States CCOP - Columbia River Oncology Program Portland Oregon
United States Kaiser Permanente Health Care - Portland Portland Oregon
United States Legacy Emanuel Hospital and Health Center and Children's Hospital Portland Oregon
United States Legacy Good Samaritan Hospital & Comprehensive Cancer Center Portland Oregon
United States Providence Cancer Center at Providence Portland Medical Center Portland Oregon
United States Providence St. Vincent Medical Center Portland Oregon
United States Harrison Poulsbo Hematology and Onocology Poulsbo Washington
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Miriam Hospital Providence Rhode Island
United States Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island
United States St. Mary - Corwin Regional Medical Center Pueblo Colorado
United States Good Samaritan Cancer Center Puyallup Washington
United States Duke Health Raleigh Hospital Raleigh North Carolina
United States Rapid City Regional Hospital Rapid City South Dakota
United States St. Joseph Medical Center Reading Pennsylvania
United States Mercy Regional Cancer Center at Mercy Medical Center Redding California
United States Annie Penn Cancer Center Reidsville North Carolina
United States Valley Medical Center Renton Washington
United States Ministry Medical Group at Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Clinic - Indianhead Center Rice Lake Wisconsin
United States Reid Hospital & Health Care Services Richmond Indiana
United States Virginia Cancer Institute - West End Richmond Virginia
United States Carilion Cancer Center of Western Virginia Roanoke Virginia
United States Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Highland Hospital of Rochester Rochester New York
United States James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York
United States Lipson Cancer and Blood Center at Rochester General Hospital Rochester New York
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Center for Cancer Care at OSF Saint Anthony Medical Center Rockford Illinois
United States Swedish-American Regional Cancer Center Rockford Illinois
United States Person Memorial Hospital Roxboro North Carolina
United States William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan
United States University of California Davis Cancer Center Sacramento California
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States CentraCare Clinic - River Campus Saint Cloud Minnesota
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeside Cancer Specialists, PLLC Saint Joseph Michigan
United States Arch Medical Services, Incorporated at Center for Cancer Care and Research Saint Louis Missouri
United States CCOP - St. Louis-Cape Girardeau Saint Louis Missouri
United States David C. Pratt Cancer Center at St. John's Mercy Saint Louis Missouri
United States Midwest Hematology Oncology Group, Incorporated Saint Louis Missouri
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States United Hospital Saint Paul Minnesota
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Peninsula Regional Medical Center Salisbury Maryland
United States Naval Medical Center - San Diego San Diego California
United States California Pacific Medical Center - California Campus San Francisco California
United States Doctors Medical Center - San Pablo Campus San Pablo California
United States Sutter Health - Western Division Cancer Research Group San Rafael California
United States North Coast Cancer Care, Incorporated Sandusky Ohio
United States Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia
United States Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah Georgia
United States Maine Center for Cancer Medicine and Blood Disorders - Scarborough Scarborough Maine
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States Hematology and Oncology Associates of Northeastern Pennsylvania Scranton Pennsylvania
United States Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania
United States CCOP - Virginia Mason Research Center Seattle Washington
United States Group Health Central Hospital Seattle Washington
United States Minor and James Medical, PLLC Seattle Washington
United States Polyclinic First Hill Seattle Washington
United States Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington
United States University Cancer Center at University of Washington Medical Center Seattle Washington
United States Grand View Hospital Sellersville Pennsylvania
United States St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota
United States Shawnee Mission Medical Center Shawnee Mission Kansas
United States Vince Lombardi Cancer Clinic - Sheboygan Sheboygan Wisconsin
United States Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming
United States Medical X-Ray Center, PC Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States Somerset Medical Center Somerville New Jersey
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology-Oncology, PC - South Bend South Bend Indiana
United States Saint Joseph Regional Medical Center South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Evergreen Hematology and Oncology, PS Spokane Washington
United States Providence Cancer Center at Holy Family Hospital Spokane Washington
United States Providence Cancer Center at Sacred Heart Medical Center Spokane Washington
United States Rockwood Clinic Cancer Treatment Center Spokane Washington
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States Mercy Medical Center Springfield Ohio
United States Regional Cancer Center at Memorial Medical Center Springfield Illinois
United States St. John's Regional Health Center Springfield Missouri
United States Lakeland Regional Cancer Care Center - St. Joseph St. Joseph Michigan
United States Regions Hospital Cancer Care Center St. Paul Minnesota
United States Mount Nittany Medical Center State College Pennsylvania
United States Iredell Memorial Hospital Statesville North Carolina
United States Saint Michael's Hospital Cancer Center Stevens Point Wisconsin
United States Stony Brook University Cancer Center Stony Brook New York
United States Aurora Medical Center Summit Wisconsin
United States Overlook Hospital Summit New Jersey
United States Flower Hospital Cancer Center Sylvania Ohio
United States SUNY Upstate Medical University Hospital Syracuse New York
United States Allenmore Hospital Tacoma Washington
United States CCOP - Northwest Tacoma Washington
United States Franciscan Cancer Center at St. Joseph Medical Center Tacoma Washington
United States Madigan Army Medical Center - Tacoma Tacoma Washington
United States MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma Washington
United States St. Clare Hospital Tacoma Washington
United States North Suburban Medical Center Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States CCOP - Toledo Community Hospital Toledo Ohio
United States Medical University of Ohio Cancer Center Toledo Ohio
United States St. Anne Mercy Hospital Toledo Ohio
United States St. Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic, Incorporated - Main Clinic Toledo Ohio
United States Toledo Hospital Toledo Ohio
United States Cotton-O'Neil Cancer Center Topeka Kansas
United States St. Francis Comprehensive Cancer Center Topeka Kansas
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Tahoe Forest Cancer Center Truckee California
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma
United States Vince Lombardi Cancer Clinic - Two Rivers Two Rivers Wisconsin
United States Carle Cancer Center at Carle Foundation Hospital Urbana Illinois
United States CCOP - Carle Cancer Center Urbana Illinois
United States Faxton Regional Cancer Center Utica New York
United States Southwest Washington Medical Center Cancer Center Vancouver Washington
United States Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare Vineland New Jersey
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States St. John Macomb Hospital Warren Michigan
United States Kent County Memorial Hospital Warwick Rhode Island
United States Marion L. Shepard Cancer Center at Beaufort County Hospital Washington North Carolina
United States Sibley Memorial Hospital Washington District of Columbia
United States Walter Reed Army Medical Center Washington District of Columbia
United States Waukesha Memorial Hospital Regional Cancer Center Waukesha Wisconsin
United States Marshfield Clinic - Wausau Center Wausau Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Wenatchee Valley Medical Center Wenatchee Washington
United States Palm Beach Cancer Institute - West Palm Beach West Palm Beach Florida
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Noble Hospital Westfield Massachusetts
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Clinton Memorial Hospital Wilmington Ohio
United States Zimmer Cancer Center at New Hanover Regional Medical Center Wilmington North Carolina
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota
United States Cleveland Clinic - Wooster Wooster Ohio
United States UMASS Memorial Cancer Center - University Campus Worcester Massachusetts
United States United States Air Force Medical Center - Wright-Patterson Wright-Patterson Afb Ohio
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington

Sponsors (2)

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

Countries where clinical trial is conducted

United States,  South Africa, 

References & Publications (2)

Baldwin RM, Owzar K, Zembutsu H, Chhibber A, Kubo M, Jiang C, Watson D, Eclov RJ, Mefford J, McLeod HL, Friedman PN, Hudis CA, Winer EP, Jorgenson EM, Witte JS, Shulman LN, Nakamura Y, Ratain MJ, Kroetz DL. A genome-wide association study identifies novel — View Citation

Shulman LN, Cirrincione CT, Berry DA, Becker HP, Perez EA, O'Regan R, Martino S, Atkins JN, Mayer E, Schneider CJ, Kimmick G, Norton L, Muss H, Winer EP, Hudis C. Six cycles of doxorubicin and cyclophosphamide or Paclitaxel are not superior to four cycles — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of DFS up to 6.4 years No
Secondary Overall survival up to 15 years No
Secondary Incidence of adverse events, graded according to the revised National Cancer Institute Common Terminology Criteria for Adverse Events 4.0 Up to 6 weeks post-treatment Yes
Secondary Time to distant metastases Up to 15 years No
Secondary Local control Up to 15 years No
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