Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

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:	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

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).

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:

Fluorouracil
Leucovorin
Colon cancer

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Leucovorin
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients

Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on February 09, 2010