A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile in Patients Receiving Adjuvant Therapy With FOLFOX-6 After Curative Resection of Colon Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Samsung Medical Center
- Enrollment
- 2,660
- Locations
- 1
- Primary Endpoint
- disease-free survival
Study Overview
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 for Patients with Stage II/III Colon Cancer (MIDAS trial: protocol NCCCTS-467) . Patients participating in the trial will be provided with the informed consent of this parallel study, and peripheral blood and tumor tissue of those who signed the consent will be collected for germline polymorphism analysis and gene expression profile study .
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
disease-free survival
Time Frame: 6years
To estimate the interaction between disease-free survival, duration of adjuvant oxaliplatin treatment, and genotypes concerning DNA repair (ERCC1, XPD, XRCC1) and detoxification (GSTP1)
Secondary Outcomes
No secondary outcomes reported
Investigators
Young Suk Park
Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology
Samsung Medical Center