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.
- 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)
- Colon cancer
- R1, R2; carcinosis peritonei
- Start of treatment > 42 days postop; other adjuvant radiotherapy, chemotherapy or
- Previous application of a murine or chimeric monoclonal antibody or antibody fragment
- Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months
- Known hypersensitivity to animal protein
- Serious concomitant disease: HIV, chronically inflammatory intestine, diabetes mell.
gravis, cerebral seizure disorder, et al.
- Pregnancy or lactation