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NCT01472601 Clinical Trial

A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile

Colon Cancer Clinical Trial

Official title:
A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile in Patients Receiving Adjuvant Therapy With FOLFOX-6 After Curative Resection of Colon Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01472601
Other study ID # 2011-04-098
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 24, 2011
Est. completion date April 2020

Study information
Verified date May 2019
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2660
Est. completion date April 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samsung medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary disease-free survival To estimate the interaction between disease-free survival, duration of adjuvant oxaliplatin treatment, and genotypes concerning DNA repair (ERCC1, XPD, XRCC1) and detoxification (GSTP1) 6years
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