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

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ClinicalTrials.gov Identifier: NCT00309530
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : April 3, 2006
Sponsor:
Information provided by:
Austrian Breast & Colorectal Cancer Study Group

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Stage III Drug: 5-fluorouracil, levamisol, interferon Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 598 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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).
Study Start Date : October 1990

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Recurrence-free survival
  2. Overall survival


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Medical University Vienna, General Hospital
Vienna, Austria, 1090
Wilheminenspital, Internal Medicin I
Vienna, Austria, 1160
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Investigators
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group

Additional Information:
ClinicalTrials.gov Identifier: NCT00309530     History of Changes
Other Study ID Numbers: ABCSG 90
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: April 3, 2006
Last Verified: April 1999

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
Fluorouracil
Levamisol
Interferon
Colon cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Interferons
Fluorouracil
Levamisole
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Antirheumatic Agents