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

King Faisal Specialist Hospital & Research Center15 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colon Rectal Cancer Duke Stage Stageval

Interventions

Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)DRUG

Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)

Eligibility

Sex: ALLMin age: 14 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Localized Non-Metastatic Rectal Cancer Exclusion Criteria: * Patients with diagnosis other than Localized Non-Metastatic Rectal Cancer

Locations (1)

Kfsh & Rc

Riyadh, Saudi Arabia

Outcomes

Primary Outcomes

Evaluate the safety of pre-operative concurrent chemotherapy with capacitabine (Xeloda), weekly cetuximab (Erbitux), and external beam radiation.

Time frame: For the duration of the experiment

Secondary Outcomes

Evaluate efficacy of sphincter preserving surgery rate, local recurrence rate and the disease free and overall survival in patients.

Time frame: For the duration of the experiment

Data from ClinicalTrials.gov

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