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A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer
This study is currently recruiting participants.
Verified by Alberta Cancer Board, July 2006
Sponsored by: Alberta Cancer Board
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00122291
  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 II

MedlinePlus related topics: Cancer
Drug Information available for: Capecitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer

Further study details as provided by Alberta Cancer Board:

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

Contacts
Contact: Alexander Chan, MD 403-521-3013 alexc@cancerboard.ab.ca
Contact: Alfred Wong, MD

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Rachel Syme, PhD            
Sponsors and Collaborators
Alberta Cancer Board
Investigators
Principal Investigator: Alexander Chan, MD Alberta Cancerboard
  More Information

Study ID Numbers: Capcetabine Phase 2, 16080
Study First Received: July 20, 2005
Last Updated: July 12, 2006
ClinicalTrials.gov Identifier: NCT00122291  
Health Authority: Canada: Health Canada

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

Study placed in the following topic categories:
Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Rectal neoplasm
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Neoplastic Processes
Neoplasms
Antimetabolites, Antineoplastic
Pathologic Processes
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009