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Thymidylate Synthase Polymorphisms as a Predictor of Toxicity to 5-Fluorouracil Based Chemotherapy in Stage III Colon Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Alberta Cancer Board
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00131599
  Purpose

Cancer of the colon and rectum are the third most common cancers in Canadian males and females. The initial therapy of colorectal cancer is surgery to remove the cancer and nearby lymph glands. If the cancer has spread to the lymph glands there is a high chance that the cancer will come back. To reduce the risk of the cancer recurring, patients are treated with an anticancer drug 5-fluorouracil (5FU) in combination with a vitamin leucovorin (LV). This study will determine if a simple blood test can predict which patients are at risk for developing side effects from this chemotherapy. In addition, participants of this study will be followed to determine if this same blood test will predict which patients will have their cancer relapse.


Condition Intervention
Colon Cancer
Drug: 5FU/LV

MedlinePlus related topics: Cancer
Drug Information available for: Fluorouracil
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Thymidylate Synthase Polymorphisms as a Predictor of Toxicity to 5-Fluorouracil Based Chemotherapy in Stage III Colon Cancer

Further study details as provided by Alberta Cancer Board:

Estimated Enrollment: 104
Study Start Date: August 2002
Estimated Study Completion Date: December 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be treated with 5FU/LV

Exclusion Criteria:

  • Abnormal liver or kidney function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131599

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Cancer Board
Investigators
Principal Investigator: Michael Sawyer, MD Alberta Cancer Board
  More Information

Study ID Numbers: GI-05-0021
Study First Received: August 17, 2005
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00131599  
Health Authority: Canada: Health Canada

Keywords provided by Alberta Cancer Board:
5-fluorouracil
thymidylate synthase
pharmacogenetics

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009