Resected Stage 2 (Dukes B) Colon Cancer MedDRA version: 7.0 Level: LLT Classification code 10001170
Conditions
Interventions
Trade Name: Campto (CPT-11)
Product Name: Irinotecan
Product Code: XRP4174
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Irinotecan hydrochloride, trihydrate.
CAS Nu
Sponsors
EORTC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically verified adenocarcinoma of the colon with penetration of the subserosa or serosa with no lymph node metastasis (UICC stage II ; pT3N0 or pT4 N0 lesions), no distant metastasis. Proximal, distal and radial margins must be free of tumor (R0 resection) - At least 12 analyzed lymph nodes - Curative radical resection within the last 56 days (8 weeks) before randomization - The gross distal margin of the primary tumor must lie above the peritoneal reflection (it must be a colon, not a rectal cancer) - Patients with more than one synchronous primary colon tumor are eligible. The stage will be the one of the most advanced tumor - Age >18 years and 10 g/dl) - Adequate hepatic and renal function (bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Known Gilbert's syndrome - Rectal tumor - Prior malignant disease (with the exception of adequately treated basal cell carcinoma of the skin and adequately treated carcinoma in situ of the cervix) - Prior chemo or radiotherapy - Any severe comorbidity - Any contraindication to the study drugs - Severe or uncontrolled coronary heart disease, severe heart failure, uncontrolled arterial hypertension - Cardiac arrhythmia without proper anticoagulant therapy (aspirin is not accepted in this case) - Myocardial infarction or vascular cerebral accident within 12 months before surgery - Known familial adenomatous polyposis (FAP) or other hereditary syndrome (Gardner’s syndrome, Turcot’s syndrome, HNPCC, etc.), Crohn’s disease or ulcerative colitis - Pregnant and lactating patients or fertile patients that cannot ensure adequate contraception for up to 6 months after completion of chemotherapy - Known allergy to folinic acid Note: Surgery and pathological processing can be detailed in an administrative appendix to this protocol,specific for each group involved in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial is designed to investigate whether combined adjuvant chemotherapy (High Dose infusional 5- FU regimens + CPT-11) is superior to observation in patients who had curative resection of a Stage II Colon Cancer. - PRIMARY: to determine whether adjuvant treatment with 5FU±FA+CPT11 increases 5-year disease-free survival from 76% to 82% (absolute difference 6%, equivalent to a HR 0.72) in patients having undergone resection of a Stage II (pT3N0 or pT4N0) colon cancer.;Secondary Objective: - SECONDARY: to determine, in the same patient population, the treatment effect on: -overall survival : from 73% to 79% at 8 years -tolerance -clinical, histological and biological prognostic factors, predictive for outcome;Primary end point(s): Primary: 5-year disease-free survival. Secondary:-overall survival; -tolerance ; -evaluation of a panel of prognostic markers, in order to correlate it with survival and recurrence. The list of the markers will be established by the biology subcommittee. | — |
Countries
Austria, Hungary, Spain
Outcome results
None listed