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

This study has been completed.
Sponsor:
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00309530
First received: March 31, 2006
Last updated: NA
Last verified: April 1999
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Hospital Guessing
Guessing, Burgenland, Austria, 7540
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria, 7350
Hospital BHB St. Veit/Glan, Surgery
St. Veit a. d. Glan, Carinthia, Austria, 9330
State Hospital Wolfsberg
Wolfsberg, Carinthia, Austria, 9400
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
State Hospital Leoben, Surgery
Leoben, Styria, Austria, 8700
Hospital St. Vinzenz
Zams, Tyrol, Austria, 6511
State Hospital Kirchdorf
Kirchdorf, Upper Austria, Austria, 4560
General Hospital Linz
Linz, Upper Austria, Austria, 4020
Hospital BHB Linz
Linz, Upper Austria, Austria, 4020
State Hospital Voecklabruck, Internal Medicine
Voecklabruck, Upper Austria, Austria, 4840
Hospital Kreuzschwestern Wels
Wels, Upper Austria, Austria, 4600
State Hospital Feldkirch
Feldkirch, Vorarlberg, Austria, 6807
Paracelsus Medical University Salzburg - Oncology
Salzburg, Austria, 5020
Wilheminenspital, Internal Medicin I
Vienna, Austria, 1160
Medical University Vienna, General Hospital
Vienna, Austria, 1090
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:
No publications provided

ClinicalTrials.gov Identifier: NCT00309530     History of Changes
Other Study ID Numbers: ABCSG 90
Study First Received: March 31, 2006
Last Updated: March 31, 2006
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:
Carcinoma
Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Fluorouracil
Interferons
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 14, 2014