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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01310985

Enrollment

Registered

2011-03-09

Start date

2008-03-31

Completion date

2014-08-31

Last updated

2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Rectal Cancer Duke Stage Stageval

Keywords

Rectal Cancer

Brief summary

Detailed description

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

Interventions

DRUGCapecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)

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

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

14 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patients with Localized Non-Metastatic Rectal Cancer

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026