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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00122291
First received: July 20, 2005
Last updated: January 18, 2012
Last verified: August 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

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

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00122291     History of Changes
Other Study ID Numbers: 16080, Capecitabine Phase 2
Study First Received: July 20, 2005
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
preoperative
chemotherapy
radiation therapy
 rectal cancer
transmural rectal wall invasion
nodal metastasis

Additional relevant MeSH terms:
Neoplasms
Rectal Neoplasms
Neoplasm Metastasis
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
 Pathologic Processes
Capecitabine
Fluorouracil
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 May 23, 2013