A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile

NCT01472601 | Unknown

• 1 other identifier: 2011-04-098
• Study Type: observational
• Target: 2,660
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology

Study Record Dates

• First Submitted: November 13, 2011
• First Posted: November 16, 2011
• Study Start: May 24, 2011
• Primary Completion: December 1, 2019
• Study Completion: April 1, 2020
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

KR (1)