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Sponsors and Collaborators: |
Federation Nationale des Centres de Lutte Contre le Cancer Federation Francophone de Cancerologie Digestive |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005979 |
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 may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence |
Study Start Date: | February 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, disease type (occlusion vs perforation vs N2 only), delay between surgery and chemotherapy (28 days or less vs over 28 days), and age (under 65 vs 65 and over). Patients are randomized to one of two treatment arms.
Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before treatment, after 6 and 12 courses, and then at 1 year.
Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 400 patients (200 per arm) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Node positive
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
France | |
Centre Alexis Vautrin | |
Vandoeuvre-les-Nancy, France, 54511 | |
Centre Eugene Marquis | |
Rennes, France, 35064 | |
Centre Hospitalier de Bourgoin - Jallieu | |
Bourgoin-Jallieu, France, 38300 | |
Centre Hospitalier de Fleyriat | |
Bourg-En-Bresse, France, 01012 | |
Centre Hospitalier de Tarbes | |
Tarbes, France, 65013 | |
Centre Hospitalier General | |
Brive, France, 19101 | |
Centre Hospitalier Maie Madeleine | |
Forbach, France, 57600 | |
Centre Hospitalier P. Chubert | |
Vannes, France, 56260 | |
Centre Hospitalier Regionale de Vichy | |
Vichy, France, 03201 | |
Centre Hospitalier Universitaire Henri Mondor | |
Creteil, France, 94010 | |
Centre Hospitalier Universitaire | |
Reims, France, 51092 | |
Centre Hospitalier Valence | |
Valence, France, 26000 | |
Centre Leon Berard | |
Lyon, France, 69008 | |
Centre Paul Papin | |
Angers, France, 49036 | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
Montpellier, France, 34298 | |
St Joseph's Medical Center | |
Reims, France, 51056 | |
Centre Rene Huguenin | |
Saint Cloud, France, 92210 | |
CHR D'Orleans - Hopital de la Source | |
Orleans, France, 45067 | |
Clinique St. Etienne | |
Bayonne, France, 64100 | |
CRLCC Nantes - Atlantique | |
Nantes-Saint Herblain, France, 44805 | |
Faculte de Medecine | |
Dijon, France, 21033 | |
Hopital Charles Nicolle | |
Rouen, France, 76031 | |
Hopital Du Bocage | |
Dijon, France, 21034 | |
Hopitaux Universitaire de Strasbourg | |
Strasbourg, France, 67091 | |
Institut Bergonie | |
Bordeaux, France, 33076 | |
Institut Claudius Regaud | |
Toulouse, France, 31052 | |
Institut Gustave Roussy | |
Villejuif, France, F-94805 | |
Institut J. Paoli and I. Calmettes | |
Marseille, France, 13273 | |
Institut Jean Godinot | |
Reims, France, 51056 | |
Centre Regional Francois Baclesse | |
Caen, France, 14076 |
Study Chair: | Marc Ychou, MD, PhD | Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle |
Study Chair: | Jean Faivre | Federation Francophone de Cancerologie Digestive |
Study ID Numbers: | CDR0000067967, FRE-FNCLCC-ACCORD-2, FFCD-9802, EU-20014 |
Study First Received: | July 5, 2000 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00005979 History of Changes |
Health Authority: | United States: Federal Government |
stage III colon cancer adenocarcinoma of the colon |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Colonic Diseases Irinotecan Leucovorin Rectal Diseases Vitamins Micronutrients Digestive System Neoplasms Vitamin B Complex Adjuvants, Immunologic Trace Elements |
Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Recurrence Camptothecin Calcium, Dietary Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Adenocarcinoma Antineoplastic Agents, Phytogenic Colonic Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Irinotecan Physiological Effects of Drugs Leucovorin Rectal Diseases Neoplasms by Site Vitamins Therapeutic Uses Micronutrients |
Vitamin B Complex Digestive System Neoplasms Growth Substances Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Camptothecin Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colonic Neoplasms |