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Trial record 14 of 901 for:    colon cancer | Open Studies
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Thymidylate Synthase Polymorphisms as a Predictor of Toxicity to Capecitabine Chemotherapy in Colon Cancer Treatment

This study is currently recruiting participants.
Verified April 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00126867
First received: August 3, 2005
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

Cancers 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 capecitabine. 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
Colon Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thymidylate Synthase Polymorphisms as a Predictor of Toxicity to Capecitabine Based Adjuvant Chemotherapy in Colon Cancer Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Estimated Enrollment: 104
Study Start Date: May 2005
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

Inclusion Criteria:

  • High risk Stage II or III colon cancer
  • Eastern Cooperative Oncology Group performance status (ECOG P.S.) O or l
  • No prior chemotherapy
  • Complete tumor resection
  • Candidate for and planned to receive standard capecitabine
  • Adequate bone marrow reserve

Exclusion Criteria:

  • Known DED deficiencies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126867

Contacts
Contact: Karen Mulder, MD 780-432-8826 karenmul@cancerboard.ab.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact     780-432-8826     clinical_trials_cci@cancerboard.ab.ca    
Principal Investigator: Karen Mulder, MD            
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Karen Mulder, MD Alberta Health Services
Principal Investigator: Michael Sawyer, MD Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00126867     History of Changes
Other Study ID Numbers: GI-05-0049 / 21882
Study First Received: August 3, 2005
Last Updated: April 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
thymidylate synthase polymers
rapecitabine
adjuvant
colon cancer
 toxicity
Stage II colon cancer
Stage III colon cancer
adenocarcinoma of the colon

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

ClinicalTrials.gov processed this record on May 16, 2013