Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
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|ClinicalTrials.gov Identifier: NCT00005979|
Recruitment Status : Unknown
Verified September 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 4, 2009
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 or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence|
|Study Start Date :||February 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005979
|Centre Paul Papin|
|Angers, France, 49036|
|Clinique St. Etienne|
|Bayonne, France, 64100|
|Bordeaux, France, 33076|
|Centre Hospitalier de Fleyriat|
|Bourg-En-Bresse, France, 01012|
|Centre Hospitalier de Bourgoin - Jallieu|
|Bourgoin-Jallieu, France, 38300|
|Centre Hospitalier General|
|Brive, France, 19101|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre Hospitalier Universitaire Henri Mondor|
|Creteil, France, 94010|
|Faculte de Medecine|
|Dijon, France, 21033|
|Hopital Du Bocage|
|Dijon, France, 21034|
|Centre Hospitalier Maie Madeleine|
|Forbach, France, 57600|
|Centre Leon Berard|
|Lyon, France, 69008|
|Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|CHR D'Orleans - Hopital de la Source|
|Orleans, France, 45067|
|Institut Jean Godinot|
|Reims, France, 51056|
|St Joseph's Medical Center|
|Reims, France, 51056|
|Centre Hospitalier Universitaire|
|Reims, France, 51092|
|Centre Eugene Marquis|
|Rennes, France, 35064|
|Hopital Charles Nicolle|
|Rouen, France, 76031|
|Centre Rene Huguenin|
|Saint Cloud, France, 92210|
|Hopitaux Universitaire de Strasbourg|
|Strasbourg, France, 67091|
|Centre Hospitalier de Tarbes|
|Tarbes, France, 65013|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Hospitalier Valence|
|Valence, France, 26000|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Centre Hospitalier P. Chubert|
|Vannes, France, 56260|
|Centre Hospitalier Regionale de Vichy|
|Vichy, France, 03201|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Marc Ychou, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|
|Study Chair:||Jean Faivre||Federation Francophone de Cancerologie Digestive|