NCT00671645

Preoperative Combined RadioChemo-Molecular Target Therapy With Capecitabine, Bevacizumab, and Radiotherapy

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Austrian Breast & Colorectal Cancer Study Group · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	capecitabine, bevacizumab	Capecitabine 825 mg/m2 bid (on each therapy day of first 4 Therapy weeks) Bevacizumab 5 mg/kg weight; day 1, 15, 29

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-02-27
• Completion: 2009-02-27
• First posted: 2008-05-05
• Last updated: 2020-10-19

Locations

10 sites across 1 country: Austria