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A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile

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ClinicalTrials.gov Identifier: NCT01472601
Recruitment Status : Recruiting
First Posted : November 16, 2011
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 .

Condition or disease
Colon Cancer

Study Design

Study Type : Observational
Estimated Enrollment : 2660 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : May 24, 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
FOLFOX_6
Oxaliplatin : 85 mg/m2/day D1 Leucovorin : 200 mg/m2/day D1 5-FU : 400 mg/m2/day D1 5-FU : 2,400 mg/m2/day D1 over 46 hrs Every 2 weeks, first 6 cycles, then Leucovorin : 200 mg/m2/day D1 5-FU : 400 mg/m2/day D1 5-FU : 2,400 mg/m2/day D1 over 46 hrs Every 2 weeks, 6 cycles
FOLFOX_12
Oxaliplatin : 85 mg/m2/day D1 Leucovorin : 200 mg/m2/day D1 5-FU : 400 mg/m2/day D1 5-FU : 2,400 mg/m2/day D1 over 46 hrs Every 2 weeks, total of 12 cycles


Outcome Measures

Primary Outcome Measures :
  1. 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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472601


Contacts
Contact: mi yeon kwon, RN +82-2-3410-1248 miyeon.kwon@samsung.com

Locations
Korea, Republic of
Samsung medical Center Recruiting
Seoul, Korea, Republic of
Contact: mi yeon kwon, RN    +82-2-3410-1248    miyeon.kwon@samsung.com   
Principal Investigator: YOUNG SUK PARK, MD         
Sponsors and Collaborators
Samsung Medical Center
More Information

Responsible Party: Young Suk Park, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01472601     History of Changes
Other Study ID Numbers: 2011-04-098
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases