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Brief Title: Preoperative Combined Induction Chemotherapy With Capecitabine, Oxaliplatin, Bevacizumab and Radiotherapy
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)
Study ID: NCT01434147
Brief Summary: Phase II pilot study of a preoperative induction chemotherapy in combination with Bevacizumab followed by combined radiochemotherapy for patients with locally advanced rectal carcinoma
Detailed Description: 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital BHB St. Veit/Glan, Surgery, St. Veit a. d. Glan, Carinthia, Austria
Medical University Graz, Oncology, Graz, Styria, Austria
Medical University Innsbruck, Internal Medicine, Innsbruck, Tyrol, Austria
Klinikum Wels-Grieskirchen, Wels, Upper Austria, Austria
State Hospital Feldkirch, Radiotherapy, Feldkirch, Vorarlberg, Austria
Paracelsus Medical University Salzburg - Oncology, Salzburg, , Austria
Medical University of Vienna, General Hospital, Vienna, , Austria
Name: Dietmar Öfner, MD, Head
Affiliation: Austrian Breast & Colorectal Cancer Study Group
Role: STUDY_CHAIR
Name: Alexander de Vries, MD, Head
Affiliation: Austrian Breast & Colorectal Cancer Study Group
Role: STUDY_CHAIR
Name: Wolfgang Eisterer, MD
Affiliation: Austrian Breast & Colorectal Cancer Study Group
Role: STUDY_CHAIR