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Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B

Phase 3
Completed
Conditions
Colon Cancer Stage II
Registration Number
NCT00309543
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
636
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Overall survival
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (18)

Hospital Guessing

🇦🇹

Guessing, Burgenland, Austria

Hospital Oberpullendorf

🇦🇹

Oberpullendorf, Burgenland, Austria

Hospital BHB St. Veit/Glan, Surgery

🇦🇹

St. Veit a. d. Glan, Carinthia, Austria

State Hospital Wolfsberg

🇦🇹

Wolfsberg, Carinthia, Austria

Hospital Hainburg

🇦🇹

Hainburg, Lower Austria, Austria

Hospital Krems

🇦🇹

Krems, Lower Austria, Austria

Hospital Tulln

🇦🇹

Tulln, Lower Austria, Austria

Hospital Waidhofen/Thaya

🇦🇹

Waidhofen a. d. Thaya, Lower Austria, Austria

Hospital Wiener Neustadt, Surgery

🇦🇹

Wiener Neustadt, Lower Austria, Austria

Medical University of Graz, Oncology

🇦🇹

Graz, Styria, Austria

Scroll for more (8 remaining)
Hospital Guessing
🇦🇹Guessing, Burgenland, Austria

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