Thymidylate Synthase Polymorphisms as a Predictor of Toxicity to Capecitabine Chemotherapy in Colon Cancer Treatment
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by AHS Cancer Control Alberta
Sponsor:
AHS Cancer Control Alberta
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00126867
First received: August 3, 2005
Last updated: October 2, 2014
Last verified: October 2014
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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 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126867
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | August 3, 2005 |
| Last Updated: | October 2, 2014 |
| Health Authority: | Canada: Health Canada |
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 Colonic Diseases |
Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 28, 2016