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

Austrian Breast & Colorectal Cancer Study Group598 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

598

Conditions

Colon Cancer Stage III

Interventions

5-fluorouracil, levamisol, interferonDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (16)

Hospital Guessing

Guessing, Burgenland, Austria

Hospital Oberpullendorf

Oberpullendorf, Burgenland, Austria

Outcomes

Primary Outcomes

Recurrence-free survival

Overall survival

Data from ClinicalTrials.gov

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