Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B
Information source: Austrian Breast & Colorectal Cancer Study Group
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colon Cancer Stage II
Intervention: Fluorouracil (Drug); Leucovorin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Austrian Breast & Colorectal Cancer Study Group Official(s) and/or principal investigator(s):
Raimund Jakesz, MD, Principal Investigator, Affiliation: ABCSG
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.
Clinical Details
Official title: A Prospectively Randomized Study on Adjuvant Chemotherapy in Patients With Operated Colon Carcinoma Dukes B (Stage II; T3-4, N0, M0).
Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment
Primary outcome: Overall survival
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Paracelsus Medical University Salzburg - Oncology, Salzburg 5020, Austria
Medical University Vienna, General Hospital, Vienna 1090, Austria
Wilheminenspital, Internal Medicin I, Vienna 1160, Austria
Hospital Guessing, Guessing, Burgenland 7540, Austria
Hospital Oberpullendorf, Oberpullendorf, Burgenland 7350, Austria
Hospital BHB St. Veit/Glan, Surgery, St. Veit a. d. Glan, Carinthia 9330, Austria
State Hospital Wolfsberg, Wolfsberg, Carinthia 9400, Austria
Hospital Hainburg, Hainburg, Lower Austria 2410, Austria
Hospital Krems, Krems, Lower Austria 3500, Austria
Hospital Tulln, Tulln, Lower Austria 3430, Austria
Hospital Waidhofen/Thaya, Waidhofen a. d. Thaya, Lower Austria 3830, Austria
Hospital Wiener Neustadt, Surgery, Wiener Neustadt, Lower Austria 2700, Austria
Medical University of Graz, Oncology, Graz, Styria 8036, Austria
State Hospital Leoben, Leoben, Styria 8700, Austria
Hospital St. Vinzenz, Zams, Tyrol 6511, Austria
Hospital Kreuzschwestern Wels, Wels, Upper Austria 4600, Austria
State Hospital Kirchdorf, Kirchdorf, Upper Austria 4560, Austria
State Hospital Feldkirch, Feldkirch, Vorarlberg 6807, Austria
Additional Information
Starting date: November 1993
Last updated: March 31, 2006
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