NCT01871363

Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Pathological complete response, (pCR) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.

Conditions

• Locally Advanced Malignant Neoplasm

Interventions

Type	Name	Description
RADIATION	chemoradiation	* radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel. * capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends), * bevacizumab: at dose 5 mg/kg on days -1, 15, 31. * Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation.

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-10-01
• First posted: 2013-06-06
• Last updated: 2013-06-06

Locations

1 site across 1 country: China