Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

Phase 3

Completed

• Conditions: Colon Cancer Stage II

• Registration Number: NCT00309543
• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1993-11
• Status Verified: 2006-03
• 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: 636

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival

Trial Locations

Locations (18)

Hospital Hainburg; 🇦🇹 Hainburg, Lower Austria, Austria

Hospital Oberpullendorf; 🇦🇹 Oberpullendorf, Burgenland, Austria

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

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

State Hospital Wolfsberg; 🇦🇹 Wolfsberg, Carinthia, Austria

Hospital Waidhofen/Thaya; 🇦🇹 Waidhofen a. d. Thaya, Lower Austria, Austria

Hospital Guessing; 🇦🇹 Guessing, Burgenland, Austria

Hospital Krems; 🇦🇹 Krems, Lower Austria, Austria

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

State Hospital Leoben; 🇦🇹 Leoben, Styria, Austria

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

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

Hospital Tulln; 🇦🇹 Tulln, Lower Austria, Austria

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

Wilheminenspital, Internal Medicin I; 🇦🇹 Vienna, Austria

Hospital Wiener Neustadt, Surgery; 🇦🇹 Wiener Neustadt, Lower Austria, Austria

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

State Hospital Feldkirch; 🇦🇹 Feldkirch, Vorarlberg, Austria