Status:
UNKNOWN
A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile
Lead Sponsor:
Samsung Medical Center
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This study is a parallel translational study of a Randomized Phase III trial Investigating the Role of Oxaliplatin duration (6 Cycles Versus 12 Cycles) in modified FOLFOX-6 Regimen as Adjuvant Therapy...
Eligibility Criteria
Inclusion
- Curatively resected, histologically confirmed colon adenocarcinoma (presence of the inferior pole of the tumor above the peritoneal reflection)
- AJCC/UICC high-risk stage II, stage III colon cancer Stage II patient with high risk of relapse, if they fulfill one or more of the following criteria:(T4 tumors,bowel obstruction or perforation,vascular or lymphatic or perineural invasion)
- Patients who are participating in the randomized phase II trial of FOLFOX 6 or 12 cycles
- Patients should sign a written informed consent for this translational study before or during participating in a randomized phase III study investigating the role of oxaliplatin duration (6 cycles versus 12 cycles) in modified FOLFOX-6 regimen as adjuvant therapy for patients with stage II/III colon cancer
Exclusion
- Patients who do not agree with sampling of peripheral blood for genetic analysis
- Patients who are considered not to be suitable for this study at investigator's discretion
Key Trial Info
Start Date :
May 24 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
2660 Patients enrolled
Trial Details
Trial ID
NCT01472601
Start Date
May 24 2011
End Date
April 1 2020
Last Update
May 20 2019
Active Locations (1)
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1
Samsung medical Center
Seoul, South Korea