NCT00847119

Xeloda and Bevacizumab to Treat Rectal Cancer

ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Institut Català d'Oncologia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.
DRUG	capecitabine (Xeloda)	Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period
RADIATION	Rectal Radiotherapy	Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-06-01
• Completion: 2015-02-01
• First posted: 2009-02-19
• Last updated: 2017-08-29

Locations

1 site across 1 country: Spain