Trial Information
A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).
Inclusion Criteria:
- Patients with histologically verified, operable colon carcinoma Stage II (RO, T3-4,
N0, M0)
- Age: less than 80 years
- WHO Performance > 2
- Adequate bone marrow reserve, renal and hepatic functions
- Informed consent
Exclusion Criteria:
- Rectal cancer
- R1or R2 resection; carcinosis peritonei
- Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or
immunotherapy
- Serious concomitant disease, in particular chronically inflammatory large intestine,
cardiopathic or metabolic disease, malignant second carcinoma
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Principal Investigator
Raimund Jakesz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Austrian Breast & Colorectal Cancer Study Group
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
ABCSG 91
NCT ID:
NCT00309543
Start Date:
November 1993
Completion Date:
Related Keywords:
- Colon Cancer Stage II
- Fluorouracil
- Leucovorin
- Colon cancer
- Carcinoma
- Colonic Neoplasms