Status:
COMPLETED
Randomized Trial on Adjuvant Chemotherapy in Colon Carcinoma Dukes B
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Conditions:
Colon Cancer Stage II
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 1993
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
636 Patients enrolled
Trial Details
Trial ID
NCT00309543
Start Date
November 1 1993
Last Update
April 3 2006
Active Locations (18)
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1
Hospital Guessing
Güssing, Burgenland, Austria, 7540
2
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria, 7350
3
Hospital BHB St. Veit/Glan, Surgery
Saint Veit A. D. Glan, Carinthia, Austria, 9330
4
State Hospital Wolfsberg
Wolfsberg, Carinthia, Austria, 9400