Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

This study has been completed.

First Received on 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:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

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
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
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
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
State Hospital Leoben
Leoben, Styria, Austria, 8700
Hospital St. Vinzenz
Zams, Tyrol, Austria, 6511
State Hospital Kirchdorf
Kirchdorf, Upper Austria, Austria, 4560
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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00309543 History of Changes
Other Study ID Numbers:	ABCSG 91
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
Leucovorin
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

Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012