Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).

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.

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