Rectal Cancer Clinical Trial
Official title:
Preoperative Induction Chemotherapy in Combination With Bevacizumab Followed by Combined Chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk of Recurrence- Phase II Pilot Study With Preoperative Administration of Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin) Followed by Capecitabine (Xeloda) Plus Radiotherapy (RTx)
Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma
Induction chemotherapy combined with Radio chemotherapy:
Therapy start: within 28 days after bioptical diagnosis capecitabine 1000 mg/m2 bid during
14 days (d1-d14) , oxaliplatin 130 mg/m2 and bevacizumab 7.5 mg/kg body weight d1;
repetition day 22 and 43 (3 cycles)
Combined Radiochemotherapy after 1 week of concluded 3rd cycle of induction chemotherapy:
Radiotherapy: 5 x 5 days 1.8 Gy; cumulative dose 45 Gy Chemotherapy: capecitabine 825mg/m²
bid, on each radiation day during the first 4 weeks of RCTx
Surgery according to TME-criteria (total mesorectal excision) in compliance of an
interruption of min. 14 days after RCTx
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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