NCT01899118

Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer

A Multicenter Phase II Trial of Nimotuzumab in Combination With Chemoradiation in Patients With Locally Advanced Rectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to evaluate the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Preoperative irradiation	50.4Gy/28F/5.5w
DRUG	Nimotuzumab	400mg/w，0-5w
DRUG	Oxaliplatin	130mg/m2 d1
DRUG	Capecitabine	825mg/m2 bid d1-5/w,1-5w

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-04-01
• First posted: 2013-07-15
• Last updated: 2013-07-15

Locations

1 site across 1 country: China