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Brief Title: Preoperative Combined RadioChemo-Molecular Target Therapy With Capecitabine, Bevacizumab, and Radiotherapy
Official Title: Preoperative Combined RadioChemo-MolecularTargetTherapy of the Locally Advanced Rectum Carcinoma (cT3NxM0) - a Phase II Pilot Study With Preoperative Application of Capecitabine, Bevacizumab and Radiotherapy (RTx)
Study ID: NCT00671645
Brief Summary: * feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma * collection of response rate (T- and M-downstaging, pathological complete remission)
Detailed Description: Combined RadioChemotherapy: Therapy start: within 28 days after bioptical diagnosis Radiotherapy: 5 x 5 days 1.8 Gy radiotherapy; cummulative dose 45 Gy Chemotherapy: Capecitabin 825mg/m² bid, on each radiation day during the first 4 weeks RCTx Molecular Targeted Therapy: Bevacizumab 5 mg/kg body weight; day 1, 15, 29 Operation due to TME adherence to a break of min. 42 to max. 56 days after the last application of bevacizumab
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital BHB St. Veit/Glan, Surgery, St. Veit/Glan, Carinthia, Austria
Medical University Graz, Oncology, Graz, Styria, Austria
State Hospital Leoben, Surgery, Leoben, Styria, Austria
Medical University Innsbruck, Internal Medicine, Innsbruck, Tyrol, Austria
Hospital BHS Linz, Radiooncology, Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen, Coop. Group, Wels, Upper Austria, Austria
State Hospital Feldkirch, Radiotherapy, Feldkirch, Vorarlberg, Austria
State Hospital Salzburg-Paracelsius Medical University - Oncology, Salzburg, , Austria
Hospital BHB Vienna, Surgery, Vienna, , Austria
Medical University Vienna, Radiotherapy, Vienna, , Austria
Name: Dietmar Oefner, MD, MSc
Affiliation: Austrian Breast & Colorectal Cancer Study Group
Role: PRINCIPAL_INVESTIGATOR
Name: Alexander de Vries, MD
Affiliation: Austrian Breast & Colorectal Cancer Study Group
Role: PRINCIPAL_INVESTIGATOR
Name: Wolfgang Eisterer, MD
Affiliation: ABCSG, TAKO
Role: PRINCIPAL_INVESTIGATOR