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Comparison of Adjuvant Chemotherapy Regimens in Treating Patients With Stage II or Stage III Rectal Cancer Who Are Receiving Radiation Therapy and Fluorouracil Before or After Surgery
This study is ongoing, but not recruiting participants.
First Received: September 10, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068692
  Purpose

RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which adjuvant combination chemotherapy regimen is more effective in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for rectal cancer.

PURPOSE: This randomized phase III trial is comparing the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who are receiving radiation therapy and fluorouracil either before or after surgery for stage II or stage III rectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: FOLFIRI regimen
Drug: FOLFOX regimen
Drug: capecitabine
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Intergroup Randomized Phase III Study Of Postoperative Irinotecan, 5-Fluorouracil And Leucovorin Vs Oxaliplatin, 5-Flourouracil And Leucovorin Vs 5-Fluorouracil And Leucovorin For Patients With Stage II or III Rectal Cancer Receiving Either Preoperative Radiation And 5-Fluorouracil Or Postoperative Radiation And 5-Flourouracil

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the rectum

    • Stage II or III (T3-4, N0, M0 or any T, N1-3, M0)
  • No distant metastases

    • No evidence of tumor outside of the pelvis, including liver metastases, peritoneal seeding, or metastatic inguinal lymphadenopathy
  • Distal border of the tumor must be or have been at or below the peritoneal reflection, defined as within 12 cm of anal verge by protoscopic examination* NOTE: *Tumor with a portion confirmed to be below the peritoneal reflection at the time of surgery is allowed regardless of the distance by endoscopy
  • Transmural penetration of tumor through the muscularis propria by CT scan, endorectal ultrasound, or MRI (group 1)
  • Tumor must be defined prospectively by the surgeon as clinically resectable or not (group 1)
  • Tumor may be clinically fixed or initially not completely resectable (clinical stage T4, N0-2, M0) based on the presence of at least 1 of the following criteria (group 1):

    • Tumor adherent to the pelvic sidewall or sacrum on rectal examination
    • Hydronephrosis on CT scan or intravenous pyelogram OR ureteric or bladder invasion by cystoscopy and cytology or biopsy OR invasion into prostate
    • Vaginal or uterine involvement

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior or concurrent malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or other treated non-pelvic cancer from which the patient has been disease-free for more than 5 years
  • No active inflammatory bowel disease
  • No other serious medical illness that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the pelvis
  • No concurrent intraoperative radiotherapy and/or brachytherapy

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068692

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305-5216
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304-1290
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
MBCCOP - Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Veterans Affairs Medical Center - Gainesville
Gainesville, Florida, United States, 32608-1197
Veterans Affairs Medical Center - Miami
Miami, Florida, United States, 33125
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Georgia
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Evanston
Evanston, Illinois, United States, 60201
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615-7828
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611-4494
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
Burgess Health Center
Onawa, Iowa, United States, 51040
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Des Moines General Hospital
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417-2399
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
CCOP - Duluth
Duluth, Minnesota, United States, 55805
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68128-4157
Veterans Affairs Medical Center - Omaha
Omaha, Nebraska, United States, 68105
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10461
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, United States, 10466
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, United States, 11209
Veterans Affairs Medical Center - New York
New York, New York, United States, 10010
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102-1192
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15236
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States, 15240
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-6307
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States, 37212-2637
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54307-3453
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226-3596
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Peru
Instituto de Enfermedades Neoplasicas
Lima, Peru, 34
Puerto Rico
MBCCOP - San Juan
San Juan, Puerto Rico, 00921-3201
San Juan City Hospital
San Juan, Puerto Rico, 00936-7344
Veterans Affairs Medical Center - San Juan
San Juan, Puerto Rico, 00927-5800
South Africa
Pretoria Academic Hospital
Pretoria, South Africa, 0001
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Al B. Benson, MD, FACP Robert H. Lurie Cancer Center
Investigator: Bruce J. Giantonio, MD Presbyterian Medical Center
Investigator: Neal J. Meropol, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Benson AB, Catalano P, Meropol NJ, et al.: ECOG E3201: intergroup randomized phase III study of postoperative irinotecan, 5- fluorouracil (FU), leucovorin (LV) (FOLFIRI) vs oxaliplatin, FU/LV (FOLFOX) vs FU/LV for patients (pts) with stage II/ III rectal cancer receiving either pre or postoperative radiation (RT)/ FU. [Abstract] J Clin Oncol 24 (Suppl 18): A-3526, 152s, 2006.

Study ID Numbers: CDR0000327815, ECOG-E3201
Study First Received: September 10, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00068692     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the rectum
stage II rectal cancer
stage III rectal cancer

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Rectal Neoplasms
Colonic Diseases
Irinotecan
Physiological Effects of Drugs
Leucovorin
Rectal Diseases
Oxaliplatin
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients
Capecitabine
Vitamin B Complex
Digestive System Neoplasms
Growth Substances
Adjuvants, Immunologic
Enzyme Inhibitors
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Camptothecin
Pharmacologic Actions
Neoplasms
Digestive System Diseases

ClinicalTrials.gov processed this record on November 27, 2009