Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients

Sponsor
Asan Medical Center
Study ID
NCT01271582
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan, 5FU, leucovorin — DRUG
    FOLFIRI regimen every 2 weeks \[irinotecan 150mg/m2 or 180mg/m2, leucovorin 20(200)mg/m2, 5FU 400 mg/m2 (bolus) or 2400 mg/m2 (46hour infusion)\]

Study Details

The purpose of this study is to investigate the association between UGT1A1 polymorphisms and neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer treated with FOLFIRI regimen.

Key Dates

Start date
Jan 31, 2009
Status verified
Jan 2019
Primary completion
Jun 30, 2014
Completion
Dec 31, 2019

Study Design

Enrollment
1,500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFIRI
    Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI(Irinotecan, 5FU, leucovorin) regimen upto 12 cycles. (Single arm study)

Primary Outcome Measure

Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment [ Time Frame: 2 weeks ]

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