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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310985
First Posted: March 9, 2011
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
  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
Colon Rectal Cancer Duke Stage Stageval Drug: Capecitabine (Xelodaâ), XRT & 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:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: March 2008
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)
    Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)
    Other Name: Capecitabine (Xelodaâ), XRT& Cetuximab (Erbitux®)
Detailed Description:
Its a pilot study of pre-op chemotherapy and RT utilizing CAPECITABINE, XRT and CETUXIMAB in pts with locally advanced rectal carcinoma.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310985


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

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 ( Other Identifier: KFSH&RC IRB )
First Submitted: March 6, 2011
First Posted: March 9, 2011
Last Update Posted: February 25, 2016
Last Verified: December 2011
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Colonic Diseases
Capecitabine
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents