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

Austrian Breast & Colorectal Cancer Study Group

Status and phase: Completed; Phase 3

Conditions: Colon Cancer Stage III

Treatments: Drug: 5-fluorouracil, levamisol, interferon

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00309530

ABCSG 90

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)