Safety and Efficacy Study to Compare Capecitabine + Bevacizumab Versus Capecitabine, Concomitantly With Radiotherapy as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer

Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of capecitabine + bevacizumab concomitantly with radiotherapy versus capecitabine concomitantly with radiotherapy, as neoadjuvant treatment for patients with localized and resectable rectal cancer.

Timeline

Start

2009-12

Primary completion

2013-01

Completion

2016-08

Outcome

Missed primary endpoint

paper The ypCR rate was 16% in arm A and 11% in arm B (p =0.54). PMID 25886378 ↗

Publications

• Salazar R, Capdevila J, Manzano JL, Pericay C, Martinez-Villacampa M, Lopez C, Losa F, Safont MJ, Gomez-Espana A, Alonso-Orduna V, Escudero P, Gallego J, Garcia-Paredes B, Palacios A, Biondo S, Gravalos C, Aranda E; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD). Phase II randomized trial of capecitabine with bevacizumab and external beam radiation therapy as preoperative treatment for patients with resectable locally advanced rectal adenocarcinoma: long term results. BMC Cancer. 2020 Nov 27;20(1):1164. doi: 10.1186/s12885-020-07661-z.
• Salazar R, Capdevila J, Laquente B, Manzano JL, Pericay C, Villacampa MM, Lopez C, Losa F, Safont MJ, Gomez A, Alonso V, Escudero P, Gallego J, Sastre J, Gravalos C, Biondo S, Palacios A, Aranda E. A randomized phase II study of capecitabine-based chemoradiation with or without bevacizumab in resectable locally advanced rectal cancer: clinical and biological features. BMC Cancer. 2015 Feb 26;15:60. doi: 10.1186/s12885-015-1053-z.

Drugs

Indications