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Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT00535041
First received: September 21, 2007
Last updated: December 11, 2011
Last verified: December 2011
History of Changes
  Purpose

Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA


Condition Intervention
Rectal Neoplasms
 Drug: Chemotherapy, radiation therapy & surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • safety [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: September 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Chemotherapy, radiation therapy & surgery
    radiation and chemotherapy
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with localized rectal CA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535041

Locations
Saudi Arabia
KFSH&RC
Riyadh, Saudi Arabia, 1211
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Shouki Bazarbashi, MD KFSH&RC
  More Information

No publications provided

Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT00535041     History of Changes
Other Study ID Numbers: RAC#2011-031
Study First Received: September 21, 2007
Last Updated: December 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by King Faisal Specialist Hospital & Research Center:
Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
 Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013