Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C

Austrian Breast & Colorectal Cancer Study Group

Status and phase

Terminated

Phase 3

Conditions

Rectal Cancer Dukes B, Dukes C

Treatments

Drug: Fluourouracil

Drug: Leucovorin

Drug: MAb 17-1A

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00309517

ABSCG 92

Details and patient eligibility

About

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).

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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