Pharmacogenomic Study to Predict Neurotoxicity of Oxaliplatin

Completed

• Conditions: Curatively Resected Stage III Colon Cancer

• Registration Number: NCT00977717
• Lead Sponsor: Samsung Medical Center

Brief Summary

In order to explore genetic factors that may determine the neurotoxicity of oxaliplatin-based chemotherapy, germinal gene polymorphisms will be analyzed.

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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-14
• Study First Posted: 2009-09-16
• Primary Completion: 2010-01
• Status Verified: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2010-04-15
• Last Update Posted: 2010-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neuropathy	six months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of