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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by King Faisal Specialist Hospital & Research Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01310985
First received: March 6, 2011
Last updated: December 11, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention
Localized Non-Metastatic Rectal Cancer
Drug: Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by King Faisal Specialist Hospital & Research Center:

Estimated Enrollment: 15
Study Start Date: March 2008
Intervention Details:
    Drug: Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)
    Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)
    Other Name: Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   14 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Localized (Non-Metastatic) Rectal Cancer

Criteria

Inclusion Criteria:

  • Patients with Localized Non-Metastatic Rectal Cancer

Exclusion Criteria:

  • Patients with diagnosis other than Localized Non-Metastatic Rectal Cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310985

Contacts
Contact: Shouki Bazarbashi, M.D. +966-1-4423949

Locations
Saudi Arabia
Kfsh & Rc Recruiting
Riyadh, Saudi Arabia
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Shouki Bazarbashi, M.D. KFSH & RC
  More Information

No publications provided

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT01310985     History of Changes
Other Study ID Numbers: RAC# 2071-051, RAC# 2071-051
Study First Received: March 6, 2011
Last Updated: December 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by King Faisal Specialist Hospital & Research Center:
Rectal Cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014