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

Study Timeline

• Study Start: 1990-10
• Status Verified: 1999-04
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-03-31
• Last Update Submitted: 2006-03-31
• Study First Posted: 2006-04-03
• Last Update Posted: 2006-04-03

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival
Overall survival

Trial Locations

Locations (16)

Hospital St. Vinzenz; 🇦🇹 Zams, Tyrol, Austria

Hospital Guessing; 🇦🇹 Guessing, Burgenland, Austria

Medical University of Graz, Oncology; 🇦🇹 Graz, Styria, Austria

State Hospital Leoben, Surgery; 🇦🇹 Leoben, Styria, Austria

State Hospital Kirchdorf; 🇦🇹 Kirchdorf, Upper Austria, Austria

General Hospital Linz; 🇦🇹 Linz, Upper Austria, Austria

Hospital BHB Linz; 🇦🇹 Linz, Upper Austria, Austria

State Hospital Voecklabruck, Internal Medicine; 🇦🇹 Voecklabruck, Upper Austria, Austria

Paracelsus Medical University Salzburg - Oncology; 🇦🇹 Salzburg, Austria

Hospital Kreuzschwestern Wels; 🇦🇹 Wels, Upper Austria, Austria

State Hospital Feldkirch; 🇦🇹 Feldkirch, Vorarlberg, Austria

Medical University Vienna, General Hospital; 🇦🇹 Vienna, Austria

Wilheminenspital, Internal Medicin I; 🇦🇹 Vienna, Austria

State Hospital Wolfsberg; 🇦🇹 Wolfsberg, Carinthia, Austria

Hospital BHB St. Veit/Glan, Surgery; 🇦🇹 St. Veit a. d. Glan, Carinthia, Austria

Hospital Oberpullendorf; 🇦🇹 Oberpullendorf, Burgenland, Austria