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

Condition(s) targeted: Colon Cancer Stage III

Intervention: 5-fluorouracil, levamisol, interferon (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Austrian Breast & Colorectal Cancer Study Group

Official(s) and/or principal investigator(s):
Raimund Jakesz, MD, Principal Investigator, Affiliation: ABCSG

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.

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).

Study design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment

Primary outcome:

Recurrence-free survival

Overall survival

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Paracelsus Medical University Salzburg - Oncology, Salzburg 5020, Austria

Medical University Vienna, General Hospital, Vienna 1090, Austria

Wilheminenspital, Internal Medicin I, Vienna 1160, Austria

Hospital Guessing, Guessing, Burgenland 7540, Austria

Hospital Oberpullendorf, Oberpullendorf, Burgenland 7350, Austria

Hospital BHB St. Veit/Glan, Surgery, St. Veit a. d. Glan, Carinthia 9330, Austria

State Hospital Wolfsberg, Wolfsberg, Carinthia 9400, Austria

Medical University of Graz, Oncology, Graz, Styria 8036, Austria

State Hospital Leoben, Surgery, Leoben, Styria 8700, Austria

Hospital St. Vinzenz, Zams, Tyrol 6511, Austria

General Hospital Linz, Linz, Upper Austria 4020, Austria

Hospital BHB Linz, Linz, Upper Austria 4020, Austria

Hospital Kreuzschwestern Wels, Wels, Upper Austria 4600, Austria

State Hospital Kirchdorf, Kirchdorf, Upper Austria 4560, Austria

State Hospital Voecklabruck, Internal Medicine, Voecklabruck, Upper Austria 4840, Austria

State Hospital Feldkirch, Feldkirch, Vorarlberg 6807, Austria

Starting date: October 1990
Last updated: March 31, 2006