Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

Austrian Breast & Colorectal Cancer Study Group

Status and phase: Completed; Phase 3

Conditions: Colon Cancer Stage II

Treatments: Drug: Leucovorin; Drug: Fluorouracil

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00309543

ABCSG 91

Details and patient eligibility

About

This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time following surgery for colon carcinoma Stage II.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)