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

Colon Rectal Cancer Duke Stage Stageval Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310985
• Other study ID #: RAC# 2071-051
• Secondary ID: RAC# 2071-051
• Status: Completed
• Start date: March 2008
• Est. completion date: August 2014

Study information

• Verified date: December 2011
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with Localized Non-Metastatic Rectal Cancer

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Colon Rectal Cancer Duke Stage Stageval
• Colorectal Neoplasms
• Rectal Neoplasms

Intervention

Drug:
• Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)
Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)

Locations

Country	Name	City	State
Saudi Arabia	Kfsh & Rc	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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