A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile

Samsung Medical Center

Status: Unknown

Conditions: Colon Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01472601

2011-04-098

Details and patient eligibility

About

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 .

Enrollment: 2,660 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,660 participants in 2 patient groups

FOLFOX_6

Description:

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

Description:

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