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

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.

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).

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