A Trial of Pre-Operative Chemoradiotherapy Using Capecitabine, Radiation & Cetuximab, in Rectal Cancer

Completed

• Conditions: Colon Rectal Cancer Duke Stage Stageval

• Registration Number: NCT01310985
• Lead Sponsor: King Faisal Specialist Hospital & Research Center

Brief Summary

A Pilot Trial of Pre-Operative Chemoradiotherapy Using Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®) Followed by Definitive Surgery in Patients With Localized (Non-Metastatic) Rectal Cancer

Detailed Description

Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in pts with locally advanced rectal carcinoma.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2011-03-06
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-09
• Status Verified: 2011-12
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2019-02-28
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients with Localized Non-Metastatic Rectal Cancer

Exclusion Criteria

• Patients with diagnosis other than Localized Non-Metastatic Rectal Cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the safety of pre-operative concurrent chemotherapy with capacitabine (Xeloda), weekly cetuximab (Erbitux), and external beam radiation.	For the duration of the experiment

Secondary Outcome Measures

Name	Time	Method
Evaluate efficacy of sphincter preserving surgery rate, local recurrence rate and the disease free and overall survival in patients.	For the duration of the experiment

Trial Locations

Locations (1)

Kfsh & Rc; 🇸🇦 Riyadh, Saudi Arabia