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A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by AHS Cancer Control Alberta.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00122291
First Posted: July 22, 2005
Last Update Posted: January 19, 2012
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:
AHS Cancer Control Alberta
  Purpose
The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Condition Intervention Phase
Rectal Cancer Neoplasm Metastasis Drug: Capecitabine Procedure: Pelvic radiation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • safety
  • response

Estimated Enrollment: 66
Study Start Date: January 2002
Detailed Description:
The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy - proven rectal cancer
  • Transmural rectal wall invasion
  • Karnofsky performance status >70
  • Normal bone marrow, liver and kidney function

Exclusion Criteria:

  • Distant metastases
  • Prior pelvic radiation
  • Inflammatory bowel disease
  • Severe ischemic heart disease
  • Anticoagulant therapy
  • Pregnancy
  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): NCT00122291


Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Gwyn Bebb, MD Alberta Health Services
  More Information

ClinicalTrials.gov Identifier: NCT00122291     History of Changes
Other Study ID Numbers: 16080
Capecitabine Phase 2
First Submitted: July 20, 2005
First Posted: July 22, 2005
Last Update Posted: January 19, 2012
Last Verified: August 2011

Keywords provided by AHS Cancer Control Alberta:
preoperative
chemotherapy
radiation therapy
rectal cancer
transmural rectal wall invasion
nodal metastasis

Additional relevant MeSH terms:
Neoplasm Metastasis
Rectal Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
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
Antineoplastic Agents