Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309543
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : April 3, 2006
Information provided by:
Austrian Breast & Colorectal Cancer Study Group

Brief Summary:
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 or disease Intervention/treatment Phase
Colon Cancer Stage II Drug: Fluorouracil Drug: Leucovorin Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 636 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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).
Study Start Date : November 1993

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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

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

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 identifier (NCT number): NCT00309543

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
Medical University Vienna, General Hospital
Vienna, Austria, 1090
Wilheminenspital, Internal Medicin I
Vienna, Austria, 1160
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Principal Investigator: Raimund Jakesz, MD Austrian Breast & Colorectal Cancer Study Group

Additional Information: Identifier: NCT00309543     History of Changes
Other Study ID Numbers: ABCSG 91
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: April 3, 2006
Last Verified: March 2006

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

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs