Randomized Phase III Intergroup Trial in Resected Stage 2 (Dukes B) Colon Cancer: 6-Month Infusional 5FU-CPT11 (+/- Folinic Acid) Versus Observation - Determination of Biologic Predictive and Response Factors
Data Collection
Colonic Diseases+9
+ Colonic Neoplasms
+ Digestive System Diseases
Treatment Study
Summary
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Compare 5-year disease-free survival in patients with resected stage II adenocarcinoma of the colon treated with adjuvant chemotherapy comprising fluorouracil and irinotecan with or without leucovorin calcium vs no adjuvant therapy. Secondary * Compare 8-year overall survival in patients treated with these regimens. * Compare tolerability of these regimens in these patients. * Correlate clinical, histological, and biological prognostic factors with outcome in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease stage (pT3 vs pT4), pathological differentiation (poorly or undifferentiated vs well or moderately differentiated), and microsatellite instability (positive vs negative vs unknown). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients are further randomized to receive 1 of 3 adjuvant chemotherapy regimens. * Regimen A: Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1, 15, and 29. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Regimen B: Patients receive irinotecan IV over 30-90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 24 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Regimen C: Patients receive irinotecan IV over 60 minutes followed by fluorouracil IV continuously over 48 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo observation only. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 1,976 patients (988 per treatment arm \[247 each in regimens A and B of arm I and 494 in regimen C of arm I\]) will be accrued for this study within 4.5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1976 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon * Stage II disease (pT3, N0 or pT4, N0) * Penetration of the subserosa or serosa * No lymph node metastases * At least 12 lymph nodes analyzed * More than 1 synchronous primary colon tumor allowed * Staging determined for the more advanced tumor * Curative radical resection within the past 2-8 weeks required * Proximal, distal, and radical margins must be free of tumor (R0 resection) * No rectal tumors * Gross distal margin of the primary tumor must lie above the peritoneal reflection * No known familial adenomatous polyposis * No hereditary nonpolyposis colorectal cancer * No distant metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000mm\^3 * Hemoglobin ≥ 10 g/dL Hepatic * Bilirubin \< 1.25 times upper limit of normal (ULN) * No known Gilbert's syndrome Renal * Creatinine \< 1.25 times ULN Cardiovascular * No severe or uncontrolled coronary disease * No severe heart failure * No uncontrolled arterial hypertension * No myocardial infarction within the past year * No cerebral vascular accident within the past year * Cardiac arrhythmia allowed provided patient is on proper anticoagulation therapy\* NOTE: \*Aspirin is not considered proper anticoagulation Gastrointestinal * No Gardner's syndrome * No Turcot's syndrome * No Crohn's disease * No ulcerative colitis Other * No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix * No other serious disease * No contraindication to any study drugs * No known allergy to leucovorin calcium * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 6 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * See Disease Characteristics Other * No other concurrent anticancer therapy * No concurrent vitamin supplements containing folic acid
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Centre Hospitalier Universitaire Ambroise Pare - Boulogne
Boulogne-Billancourt, FranceHopital Du Bocage
Dijon, FranceMedizinische Klinik I
Dresden, Germany