Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

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

Summary

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.

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

Details

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

Criteria

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