NCT01271582Unknown4 期
Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 1,500
- 试验地点
- 5
- 主要终点
- Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects should meet all of the following criteria to participate in the trial.
- •Histologically confirmed colorectal or gastric cancer patients who are chemonaive or failed to 1st line chemotherapy
- •Subjects who are expected to receive toxicity test at least once after FOLFIRI treatment.
- •Aged 18 years or older.
- •ECOG performance status of ≤
- •Anticipated life expectancy of ≥ 3 months.
- •Clinically acceptable function of bone marrow, kidney and liver function as below.
- •ANC ≥ 1500/mm3 and platelet count ≥ 100,000/mm3
- •Serum total bilirubin ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)
- •Serum creatinine ≤ 1.5 mg/dL or CLcr > 60 ml/min
- •Subjects whose written informed consent can be obtained prior to their participation in the trial.
排除标准
- •Subjects who meet any of the following criteria should not be included in the trial.
- •Pregnant or breast feeding women
- •Serious concurrent complication, severe active infection.
- •Subjects with chronic diarrhea, paralytic ileums, pulmonary fibrosis or pneumonia interstitialis
- •Subjects with epilepsia or severe psychiatric disorders.
- •Subjects who are regarded to be unsuitable for this trial by the investigator.
- •Subjects who are participating in other clinical trials
- •Subjects who have received prior chemotherapy including irinotecan.
研究组 & 干预措施
FOLFIRI
Experimental
Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI(Irinotecan, 5FU, leucovorin) regimen upto 12 cycles. (Single arm study)
干预措施: Irinotecan, 5FU, leucovorin (Drug)
结局指标
主要结局
Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment
时间窗: 2 weeks
During the first cycle of treatment
次要结局
- Association between grade 3/4 diarrhea and UGT1A1 polymorphism(2 weeks)
- Progression-free survival(6 months (average))
- Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration(24 weeks)
研究者
Tae Won Kim
Professor
Asan Medical Center
研究点 (5)
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