A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile

NCT ID: NCT01472601

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2660 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-24
• Study Completion Date: 2020-04-30

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 .

Conditions

Colon Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Young Suk Park

Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2011-04-098

Identifier Type: -

Identifier Source: org_study_id