Clinical trial NCT00309530: Randomized Study on Adjuvant Chemotherapy and Adjuvant Chemo-Immunotherapy in Colon Carcinoma Dukes C
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Cancer Stage III
Keywords: Fluorouracil
Levamisol
Interferon
Colon cancer
Lead sponsor: Austrian Breast & Colorectal Cancer Study Group
Sponsor class: NETWORK
First posted: 2006-04-03
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Recurrence-free survival
measure: Overall survival
Secondary outcomes:
Other outcomes:
Locations:
city: Guessing
country: Austria
facility: Hospital Guessing
state: Burgenland
city: Oberpullendorf
country: Austria
facility: Hospital Oberpullendorf
state: Burgenland
city: St. Veit a. d. Glan
country: Austria
facility: Hospital BHB St. Veit/Glan, Surgery
state: Carinthia
city: Wolfsberg
country: Austria
facility: State Hospital Wolfsberg
state: Carinthia
city: Graz
country: Austria
facility: Medical University of Graz, Oncology
state: Styria
city: Leoben
country: Austria
facility: State Hospital Leoben, Surgery
state: Styria
city: Zams
country: Austria
facility: Hospital St. Vinzenz
state: Tyrol
city: Kirchdorf
country: Austria
facility: State Hospital Kirchdorf
state: Upper Austria
city: Linz
country: Austria
facility: General Hospital Linz
state: Upper Austria
city: Linz
country: Austria
facility: Hospital BHB Linz
state: Upper Austria
city: Voecklabruck
country: Austria
facility: State Hospital Voecklabruck, Internal Medicine
state: Upper Austria
city: Wels
country: Austria
facility: Hospital Kreuzschwestern Wels
state: Upper Austria
city: Feldkirch
country: Austria
facility: State Hospital Feldkirch
state: Vorarlberg
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg - Oncology
city: Vienna
country: Austria
facility: Medical University Vienna, General Hospital
city: Vienna
country: Austria
facility: Wilheminenspital, Internal Medicin I
Study officials:
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Raimund Jakesz, MD
role: PRINCIPAL_INVESTIGATOR
References: