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Sponsors and Collaborators: |
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch European Organization for Research and Treatment of Cancer Federation Francophone de Cancerologie Digestive Grupo Espanol Tratamiento Tumores Digestivos |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004150 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer.
PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: fluorouracil Drug: leucovorin calcium Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid |
Study Start Date: | March 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to regional lymph node involvement (N1 (1-3 pericolic lymph nodes) vs N2 (more than 3 pericolic lymph nodes) and participating center.
Patients are randomized to one of two treatment arms.
Patients are followed at 1 month, every 6 months for 4.5 years, and then annually thereafter until death.
PROJECTED ACCRUAL: Approximately 1,600 patients (800 per treatment arm) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have had curative radical resection within 56 days prior to study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Investigator: | Claus-Henning Koehne, MD | Klinikum Oldenburg |
Investigator: | G. Leam | Saint Laurentius Ziekenhuis |
Investigator: | Laurent Bedenne, MD | Hopital Du Bocage |
Study Chair: | Alfredo Carrato-Mena, MD | Hospital Universitario de Elche |
Study ID Numbers: | CDR0000067383, PETACC-2, EORTC-40963, FFCD-PETACC-2, GETTD-PETACC-2 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004150 History of Changes |
Health Authority: | United States: Federal Government |
stage III colon cancer adenocarcinoma of the colon mucinous adenocarcinoma of the colon |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Colonic Diseases Leucovorin Folate Rectal Diseases Vitamin B9 Vitamins Micronutrients Digestive System Neoplasms Vitamin B Complex Adjuvants, Immunologic |
Trace Elements Intestinal Diseases Folinic Acid Immunosuppressive Agents Intestinal Neoplasms Folic Acid Calcium, Dietary Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Colonic Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Neoplasms by Site Therapeutic Uses Vitamins Micronutrients |
Digestive System Neoplasms Vitamin B Complex Growth Substances Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |