A Prospectively Randomized Study on Neoadjuvant Radio-Chemotherapy in Patients With Operated Rectal Carcinoma Dukes B and C (pT2, pN1-3; pT3-4, pN0-3; M0.
Phase 3
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Both
Rectal Cancer Dukes B, Dukes C
Both
Rectal Cancer Dukes B, Dukes C
Trial Information
A Prospectively Randomized Study on Neoadjuvant Radio-Chemotherapy in Patients With Operated Rectal Carcinoma Dukes B and C (pT2, pN1-3; pT3-4, pN0-3; M0.
Inclusion Criteria:
- Patients with histologically verified operable rectal cancer Dukes B and C (Stage II,
T2-4, N0-3, M0), R0
- Age: 18-80 years
- Karnofsky Performance Status > 80
- Adequate bone marrow reserve (leukocytes > 4,000, thrombocytes > 105/mm3, Hb > 10g
%), renal and hepatic functions (total bilirubin and creatinine < 1.25 x ULN)
Exclusion Criteria:
- Colon cancer
- R1, R2; carcinosis peritonei
- Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or
immunotherapy
- Previous application of a murine or chimeric monoclonal antibody or antibody fragment
- Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months
pre-study
- Known hypersensitivity to animal protein
- Serious concomitant disease: HIV, chronically inflammatory intestine, diabetes mell.
gravis, cerebral seizure disorder, et al.
- Pregnancy or lactation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local recurrence-free survival
Principal Investigator
Raimund Jakesz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Austrian Breast & Colorectal Cancer Study Group
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
ABSCG 92
NCT ID:
NCT00309517
Start Date:
July 1997
Completion Date:
Related Keywords:
- Rectal Cancer Dukes B, Dukes C
- Fluorouracil
- Leucovorin
- MAb 17-1A
- Rectal cancer
- Carcinoma
- Rectal Neoplasms
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