Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
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Trial Identification
Brief Title: Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
Official Title: Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence
Study ID: NCT00005979
Conditions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: * Compare the effect of leucovorin calcium and fluorouracil with or without irinotecan on the 3 year survival rate and overall survival of patients with resected node positive colon cancer at high risk of recurrence. * Compare toxicities of these regimens in these patients. * Compare quality of life of these patients. 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. * Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. * Arm II: Patients receive irinotecan IV over 90 minutes on day 1 followed by leucovorin calcium and fluorouracil as in arm I. 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre Paul Papin, Angers, , France
Clinique St. Etienne, Bayonne, , France
Institut Bergonie, Bordeaux, , France
Centre Hospitalier de Fleyriat, Bourg-En-Bresse, , France
Centre Hospitalier de Bourgoin - Jallieu, Bourgoin-Jallieu, , France
Centre Hospitalier General, Brive, , France
Centre Regional Francois Baclesse, Caen, , France
Centre Hospitalier Universitaire Henri Mondor, Creteil, , France
Faculte de Medecine, Dijon, , France
Hopital Du Bocage, Dijon, , France
Centre Hospitalier Maie Madeleine, Forbach, , France
Centre Leon Berard, Lyon, , France
Institut J. Paoli and I. Calmettes, Marseille, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
CHR D'Orleans - Hopital de la Source, Orleans, , France
Institut Jean Godinot, Reims, , France
St Joseph's Medical Center, Reims, , France
Centre Hospitalier Universitaire, Reims, , France
Centre Eugene Marquis, Rennes, , France
Hopital Charles Nicolle, Rouen, , France
Centre Rene Huguenin, Saint Cloud, , France
Hopitaux Universitaire de Strasbourg, Strasbourg, , France
Centre Hospitalier de Tarbes, Tarbes, , France
Institut Claudius Regaud, Toulouse, , France
Centre Hospitalier Valence, Valence, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Centre Hospitalier P. Chubert, Vannes, , France
Centre Hospitalier Regionale de Vichy, Vichy, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Marc Ychou, MD, PhD
Affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
Role: STUDY_CHAIR
Name: Jean Faivre
Affiliation: Federation Francophone de Cancerologie Digestive
Role: STUDY_CHAIR
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