NCT00297128

Preoperative Chemoradiation With Capecitabine and Cetuximab

Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Austrian Breast & Colorectal Cancer Study Group · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

* feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma * collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
DRUG	Cetuximab	400mg/m2 week 1, 250mg/m2 week 2-4

Timeline

• Start date: 2005-10-01
• Primary completion: 2011-08-01
• Completion: 2011-11-01
• First posted: 2006-02-28
• Last updated: 2011-12-30

Locations

10 sites across 1 country: Austria