A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile
This study is currently recruiting participants.
Verified June 2013 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by (Responsible Party):
Young Suk Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01472601
First received: November 13, 2011
Last updated: June 12, 2013
Last verified: June 2013
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Purpose
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 |
|---|
|
Colon Cancer |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- disease-free survival [ Time Frame: 6years ] [ Designated as safety issue: No ]To estimate the interaction between disease-free survival, duration of adjuvant oxaliplatin treatment, and genotypes concerning DNA repair (ERCC1, XPD, XRCC1) and detoxification (GSTP1)
| Estimated Enrollment: | 2660 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 |
| Study First Received: | November 13, 2011 |
| Last Updated: | June 12, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on June 17, 2013