MedPath

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

Phase 3
Completed
Conditions
Colon Cancer Stage III
Registration Number
NCT00309530
Lead Sponsor
Austrian Breast & Colorectal Cancer Study Group
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
598
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
Recurrence-free survival
Overall survival
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (16)

Hospital Guessing

🇦🇹

Guessing, Burgenland, Austria

Hospital Oberpullendorf

🇦🇹

Oberpullendorf, Burgenland, Austria

Hospital BHB St. Veit/Glan, Surgery

🇦🇹

St. Veit a. d. Glan, Carinthia, Austria

State Hospital Wolfsberg

🇦🇹

Wolfsberg, Carinthia, Austria

Medical University of Graz, Oncology

🇦🇹

Graz, Styria, Austria

State Hospital Leoben, Surgery

🇦🇹

Leoben, Styria, Austria

Hospital St. Vinzenz

🇦🇹

Zams, Tyrol, Austria

State Hospital Kirchdorf

🇦🇹

Kirchdorf, Upper Austria, Austria

General Hospital Linz

🇦🇹

Linz, Upper Austria, Austria

Hospital BHB Linz

🇦🇹

Linz, Upper Austria, Austria

Scroll for more (6 remaining)
Hospital Guessing
🇦🇹Guessing, Burgenland, Austria

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.