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Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B
This study has been completed.
Sponsored by: Austrian Breast & Colorectal Cancer Study Group
Information provided by: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier: NCT00309543
  Purpose

This clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients’ survival time following surgery for colon carcinoma Stage II.


Condition Intervention Phase
Colon Cancer Stage II
Drug: Fluorouracil
Drug: Leucovorin
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Liothyronine sodium Triiodothyronine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment
Official Title: A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).

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

Primary Outcome Measures:
  • Overall survival

Estimated Enrollment: 636
Study Start Date: November 1993
  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, operable colon carcinoma Stage II (RO, T3-4, N0, M0)
  • Age: less than 80 years
  • WHO Performance > 2
  • Adequate bone marrow reserve, renal and hepatic functions
  • Informed consent

Exclusion Criteria:

  • Rectal cancer
  • R1or R2 resection; carcinosis peritonei
  • Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
  • Serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic or metabolic disease, malignant second carcinoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309543

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, Lower Austria
Hospital Hainburg
Hainburg, Lower Austria, Austria, 2410
Hospital Krems
Krems, Lower Austria, Austria, 3500
Hospital Tulln
Tulln, Lower Austria, Austria, 3430
Hospital Waidhofen/Thaya
Waidhofen a. d. Thaya, Lower Austria, Austria, 3830
Hospital Wiener Neustadt, Surgery
Wiener Neustadt, Lower Austria, Austria, 2700
Austria, Styria
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
State Hospital Leoben
Leoben, Styria, Austria, 8700
Austria, Tyrol
Hospital St. Vinzenz
Zams, Tyrol, Austria, 6511
Austria, Upper Austria
Hospital Kreuzschwestern Wels
Wels, Upper Austria, Austria, 4600
State Hospital Kirchdorf
Kirchdorf, Upper Austria, Austria, 4560
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

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: ABCSG 91
Study First Received: March 31, 2006
Last Updated: March 31, 2006
ClinicalTrials.gov Identifier: NCT00309543  
Health Authority: Austria: Federal Ministry for Health and Women

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

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil
Colonic Diseases
Leucovorin
Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms
Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 14, 2009