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).
NCT number | NCT00309543 |
Other study ID # | ABCSG 91 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | March 31, 2006 |
Last updated | March 31, 2006 |
Start date | November 1993 |
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.
Status | Completed |
Enrollment | 636 |
Est. completion date | |
Est. primary completion date | |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Austrian Breast & Colorectal Cancer Study Group |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival |
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