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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group
• Treatments: Fluorouracil; Interferons

Criteria

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