Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C

A Prospectively Randomized Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0).

This clinical investigation examined the effectivity 5-fluorouracil, of adding levamisol or interferon to 5-fluorouracil, and of a 5-fluorouracil/levamisol/interferon triple combination, in terms of recurrence-free and overall survival in curatively operable colon carcinoma Stage III.

Inclusion Criteria:

• Patients with histologically verified, curatively operated colon carcinoma Stage III (R0, T1-4, N1-3, M0)
• Age: less than 80 years
• WHO Performace Status > 2
• Adequate bone marrow reserve
• Informed consent

Exclusion Criteria:

• Rectal cancer
• R1, R2, carcinosis peritonei
• Start of chemo- or chemo-immunotherapy > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
• Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic disease, malignant second carcinoma