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

This study has been completed.

First Received: March 31, 2006 No Changes Posted

Sponsor:	Austrian Breast & Colorectal Cancer Study Group
Information provided by:	Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00309530

Purpose

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.

Condition	Intervention	Phase
Colon Cancer Stage III	Drug: 5-fluorouracil, levamisol, interferon	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment
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).

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Interferons

U.S. FDA Resources

Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:

Recurrence-free survival
Overall survival

Estimated Enrollment:	598
Study Start Date:	October 1990

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309530

Locations

Austria
Paracelsus Medical University Salzburg - Oncology
Salzburg, Austria, 5020
Medical University Vienna, General Hospital
Vienna, Austria, 1090
Wilheminenspital, Internal Medicin I
Vienna, Austria, 1160
Austria, Burgenland
Hospital Guessing
Guessing, Burgenland, Austria, 7540
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria, 7350
Austria, Carinthia
Hospital BHB St. Veit/Glan, Surgery
St. Veit a. d. Glan, Carinthia, Austria, 9330
State Hospital Wolfsberg
Wolfsberg, Carinthia, Austria, 9400
Austria, Styria
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
State Hospital Leoben, Surgery
Leoben, Styria, Austria, 8700
Austria, Tyrol
Hospital St. Vinzenz
Zams, Tyrol, Austria, 6511
Austria, Upper Austria
General Hospital Linz
Linz, Upper Austria, Austria, 4020
Hospital BHB Linz
Linz, Upper Austria, Austria, 4020
Hospital Kreuzschwestern Wels
Wels, Upper Austria, Austria, 4600
State Hospital Kirchdorf
Kirchdorf, Upper Austria, Austria, 4560
State Hospital Voecklabruck, Internal Medicine
Voecklabruck, Upper Austria, Austria, 4840
Austria, Vorarlberg
State Hospital Feldkirch
Feldkirch, Vorarlberg, Austria, 6807

Sponsors and Collaborators

Austrian Breast & Colorectal Cancer Study Group

Investigators

Principal Investigator:

Raimund Jakesz, MD

Austrian Breast & Colorectal Cancer Study Group

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	ABCSG 90
Study First Received:	March 31, 2006
Last Updated:	March 31, 2006
ClinicalTrials.gov Identifier:	NCT00309530 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:

Fluorouracil
Levamisol
Interferon
Colon cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Neoplasms by Site
Therapeutic Uses
Digestive System Neoplasms
Interferons

Adjuvants, Immunologic
Intestinal Diseases
Immunosuppressive Agents
Antiviral Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010