NCT01554059

Neoadjuvant Chemoradiation With Bevacizumab for Chinese Rectal Cancer Patients

Phase II Trial of Neoadjuvant Chemoradiation With Bevacizumab for Chinese Locally Advanced Rectal Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with radiotherapy as neoadjuvant treatment for patients with locally advanced but resectable rectal adenocarcinoma.

Detailed description

Primary endpoint: Pathological Complete Response Rate (pCR) Secondary endpoint: Time to Relapse, disease free survival, overall survival and safety data

Conditions

• Rectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab 5mg/m2 D1,D15,D29,D43;
DRUG	Oxaliplatin	Oxaliplatin 85mg/m2 D1,D57; Oxaliplatin 85mg/m2 biweekly \* 6 doses 3-4 weeks after radical resection
DRUG	5-FU	5-FU 2800mg/m2 civ 48 hours D1,D57; 5-FU 2800mg/m2 civ 48 hours biweekly\*6 doses 3-4 weeks after radical resection; 5-FU 200mg/m2/day civ D15-19,D22-26,D29-33,D36-40,D43-47;
RADIATION	Radiotherapy	2GY daily \*20次

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-05-01
• Completion: 2014-08-01
• First posted: 2012-03-14
• Last updated: 2014-11-10

Locations

2 sites across 1 country: China