Xeloda and Bevacizumab to Treat Rectal Cancer (xeberecto)
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|ClinicalTrials.gov Identifier: NCT00847119|
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Biological: Bevacizumab Drug: capecitabine (Xeloda) Radiation: Rectal Radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||February 2015|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|