Xeloda and Bevacizumab to Treat Rectal Cancer (xeberecto)
Recruitment status was: Active, not recruiting
|Rectal Cancer||Biological: Bevacizumab Drug: capecitabine (Xeloda) Radiation: Rectal Radiotherapy||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE|
- Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece) [ Time Frame: Surgery date ]
- Overall clinical response [ Time Frame: Surgery date ]
- To determine the downstaging caused by treatment [ Time Frame: Surgery date ]
- relapse free survival [ Time Frame: Time of radiological evidence of relapse. ]
- Quantify the local control grade: R0 resections in surgery [ Time Frame: Surgery date ]
- Local relapse and distant relapse rates [ Time Frame: Relapse date ]
- To determine the security profile of this neoadjuvant treatment (radio- chemotherapy) [ Time Frame: From date of register to surgery date ]
- Surgery complication rate [ Time Frame: During surgery admission. ]
- To determine the angiogenic profile changes in tumour. [ Time Frame: 15 days, 6 weeks and 4 months ]
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||September 2013|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab & capecitabine & radiotheraphy
Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.
Radiotherapy 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.
Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period.
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 periodRadiation: Rectal Radiotherapy
Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847119
|Institut Català d'Oncologia-L'Hospitalet|
|L'Hospitalet del Llobregat, Barcelona, Spain, 08907|
|Principal Investigator:||Ramon Salazar, Phd||Institut Català d'Oncologia|
|Study Chair:||Margarita Garcia, MD||Institut Català d'Oncologia|