Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin

This study has been completed.
Information provided by:
Samsung Medical Center Identifier:
First received: September 3, 2009
Last updated: April 15, 2010
Last verified: April 2010
In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based chemotherapy, germinal gene polymorphisms will be analyzed.

Curatively Resected Stage III Colon Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenomic Study to Predict Toxicity and Response in Colorectal Cancer Patients Treated With Oxaliplatin-based Chemotherapy

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • neuropathy [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA
DNA will be extracted from peripheral blood samples using DNA isolation kit.

Estimated Enrollment: 100
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Stage III colorectal cancer patients who are treated with adjuvant FOLFOX chemotherapy

Detailed Description:
To investigate the impact of single nucleotide (SNP) polymorphism on the toxicity profile in colorectal cancer patients treated with FOLFOX chemotherapy, 10 cc of blood will be drawn in EDTA tube for extraction. DNA will be extracted from peripheral blood samples using DNA isolation kit, and SNP polymorphisms will be evaluated.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Curatively resected stage III colon cancer

Inclusion Criteria:

  • aged 18 or older
  • curatively resected colon adenocarcinoma
  • pathologically staged III
  • adequate performance status
  • adequate major organ functions
  • to be treated with adjuvant FOLFOX chemotherapy
  • written informed consent

Exclusion Criteria:

  • those who disagree the study
  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 identifier: NCT00977717

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135 710
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Se Hoon Park, MD Samsung Medical Center, Seoul, Korea
  More Information

No publications provided

Responsible Party: Se Hoon Park, MD, Samsung Medical Center, Seoul, Korea Identifier: NCT00977717     History of Changes
Other Study ID Numbers: 2008-05-052
Study First Received: September 3, 2009
Last Updated: April 15, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:

Additional relevant MeSH terms:
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015