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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002523 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: fluorouracil Drug: leucovorin calcium Procedure: conventional surgery Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | FOUR ARMS PHASE III CLINICAL TRIAL FOR T3-T4 RESECTABLE RECTAL CANCER COMPARING PRE-OPERATIVE PELVIC IRRADIATION TO PRE-OPERATIVE IRRADIATION COMBINED WITH FLUOROURACIL AND LEUCOVORIN WITH OR WITHOUT POST-OPERATIVE ADJUVANT CHEMOTHERAPY |
Study Start Date: | April 1993 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, sex, tumor location (0-5 vs 6-10 vs 11-15 cm from anal margin), and stage (T3 vs T4). Patients are randomized to 1 of 4 treatment arms.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 992 patients will be accrued for this study within 4 years.
Ages Eligible for Study: | up to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed resectable adenocarcinoma of the rectum
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Jean-Francois Bosset, MD | Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz |
Study ID Numbers: | CDR0000078308, EORTC-22921 |
Study First Received: | November 1, 1999 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00002523 |
Health Authority: | United States: Federal Government |
stage II rectal cancer stage III rectal cancer adenocarcinoma of the rectum |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Rectal neoplasm Calcium, Dietary Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Micronutrients |