Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

Colon Cancer Stage II Clinical Trial

Official title:

A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309543
• Other study ID #: ABCSG 91
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2006
• Last updated: March 31, 2006
• Start date: November 1993

Study information

• Verified date: March 2006
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 636
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer Stage II

Intervention

Drug:
• Fluorouracil

• Leucovorin

Locations

Country	Name	City	State
Austria	State Hospital Feldkirch	Feldkirch	Vorarlberg
Austria	Medical University of Graz, Oncology	Graz	Styria
Austria	Hospital Guessing	Guessing	Burgenland
Austria	Hospital Hainburg	Hainburg	Lower Austria
Austria	State Hospital Kirchdorf	Kirchdorf	Upper Austria
Austria	Hospital Krems	Krems	Lower Austria
Austria	State Hospital Leoben	Leoben	Styria
Austria	Hospital Oberpullendorf	Oberpullendorf	Burgenland
Austria	Paracelsus Medical University Salzburg - Oncology	Salzburg
Austria	Hospital BHB St. Veit/Glan, Surgery	St. Veit a. d. Glan	Carinthia
Austria	Hospital Tulln	Tulln	Lower Austria
Austria	Medical University Vienna, General Hospital	Vienna
Austria	Wilheminenspital, Internal Medicin I	Vienna
Austria	Hospital Waidhofen/Thaya	Waidhofen a. d. Thaya	Lower Austria
Austria	Hospital Kreuzschwestern Wels	Wels	Upper Austria
Austria	Hospital Wiener Neustadt, Surgery	Wiener Neustadt	Lower Austria
Austria	State Hospital Wolfsberg	Wolfsberg	Carinthia
Austria	Hospital St. Vinzenz	Zams	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival

External Links

•   Link