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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 January 2017 by AHS Cancer Control Alberta
Sponsor:
ClinicalTrials.gov Identifier:
NCT00126867
First Posted: August 5, 2005
Last Update Posted: January 16, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  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:


Further study details as provided by AHS Cancer Control Alberta:

Estimated Enrollment: 104
Study Start Date: May 2005
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00126867


Contacts
Contact: Karen Mulder, MD 780-432-8248 karen.mulder@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact    780-432-8248      
Principal Investigator: Karen Mulder, MD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Karen Mulder, MD AHS Cancer Control Alberta
Principal Investigator: Michael Sawyer, MD AHS Cancer Control Alberta
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00126867     History of Changes
Other Study ID Numbers: GI-05-0049 / 21882
First Submitted: August 3, 2005
First Posted: August 5, 2005
Last Update Posted: January 16, 2017
Last Verified: January 2017

Keywords provided by AHS Cancer Control Alberta:
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
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents