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A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile in Patients Receiving Adjuvant Therapy With FOLFOX-6 After Curative Resection of Colon Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer

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Trial Information

A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile in Patients Receiving Adjuvant Therapy With FOLFOX-6 After Curative Resection of Colon Cancer


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

disease-free survival

Outcome Description:

To estimate the interaction between disease-free survival, duration of adjuvant oxaliplatin treatment, and genotypes concerning DNA repair (ERCC1, XPD, XRCC1) and detoxification (GSTP1)

Outcome Time Frame:

6years

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

2011-04-098

NCT ID:

NCT01472601

Start Date:

June 2011

Completion Date:

April 2017

Related Keywords:

  • Colon Cancer
  • Colonic Neoplasms

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