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

Colon Cancer Stage III Clinical Trial

Official title:

A Prospectively Randomized Phase III Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Patients With Operated Colon Carcinoma Dukes C (Stage III; T1-4, N1-30, M0).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309530
• Other study ID #: ABCSG 90
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2006
• Last updated: March 31, 2006
• Start date: October 1990

Study information

• Verified date: April 1999
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer Stage III

Intervention

Drug:
• 5-fluorouracil, levamisol, interferon

Locations

Country	Name	City	State
Austria	State Hospital Feldkirch	Feldkirch	Vorarlberg
Austria	Medical University of Graz, Oncology	Graz	Styria
Austria	Hospital Guessing	Guessing	Burgenland
Austria	State Hospital Kirchdorf	Kirchdorf	Upper Austria
Austria	State Hospital Leoben, Surgery	Leoben	Styria
Austria	General Hospital Linz	Linz	Upper Austria
Austria	Hospital BHB Linz	Linz	Upper Austria
Austria	Hospital Oberpullendorf	Oberpullendorf	Burgenland
Austria	Paracelsus Medical University Salzburg - Oncology	Salzburg
Austria	Hospital BHB St. Veit/Glan, Surgery	St. Veit a. d. Glan	Carinthia
Austria	Medical University Vienna, General Hospital	Vienna
Austria	Wilheminenspital, Internal Medicin I	Vienna
Austria	State Hospital Voecklabruck, Internal Medicine	Voecklabruck	Upper Austria
Austria	Hospital Kreuzschwestern Wels	Wels	Upper Austria
Austria	State Hospital Wolfsberg	Wolfsberg	Carinthia
Austria	Hospital St. Vinzenz	Zams	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free survival
Primary	Overall survival

External Links

•   Link