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.

Austrian Breast & Colorectal Cancer Study Group8 sites in 1 country700 target enrollmentJuly 1997

ConditionsRectal Cancer Dukes B, Dukes C

DrugsFluourouracil Leucovorin MAb 17-1A

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rectal Cancer Dukes B, Dukes C
Sponsor: Austrian Breast & Colorectal Cancer Study Group
Enrollment: 700
Locations: 8
Primary Endpoint: Local recurrence-free survival
Status: Terminated
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).

Registry

clinicaltrials.gov

Start Date

July 1997

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Austrian Breast & Colorectal Cancer Study Group

Eligibility Criteria

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