Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Objective tumor response
研究概览
简要总结
In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.
详细描述
A new oral DPD inhibitory fluoropyrimidine (DIF), S-1, is reportedly effective against gastrointestinal carcinoma. In this study, the relationship between activity of DPD in peripheral blood and the effects of chemotherapy were investigated in 200 patients treated with first-line S-1 combined with platinum chemotherapy for gastrointestinal carcinoma.
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
- •Histologically or cytologically confirmed gastrointestinal cancer；
- •Physician's intention to treat with S-1 combined with platinum regimen on disease status and clinical judgment;
- •Life expectancy of at least three months;
- •Written informed consent to participate in the trial;
排除标准
- •History of severe hypersensitivity reactions to the ingredients of S-1 or oxaliplatin;
- •Inadequate hematopoietic function which is defined as below:
- •white blood cell (WBC) less than 3,500/mm^3
- •absolute neutrophil count (ANC) less than 1,500/mm^3
- •platelets less than 80,000/mm^3
- •Inadequate hepatic or renal function which is defined as below:
- •serum bilirubin greater than 1.5 times the upper limit of normal range
- •alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- •greater than 2.5 times the ULN if no demonstrable liver metastases or
- •greater than 5 times the ULN in the presence of liver metastases
- •blood creatinine level greater than 2 times ULN
- •Presence of peripheral neuropathy;
- •Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug;
- •Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male);
- •Psychiatric disorder or symptom that makes participation of the patient difficult;
- •Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months;
- •Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes;
- •Known DPD deficiency;
- •Receiving a concomitant treatment with sorivudine or Brivudine within two months;
研究组 & 干预措施
S-1 plus oxaliplatin
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.
干预措施: S-1 plus oxaliplatin (Drug)
结局指标
主要结局
Objective tumor response
时间窗: Every eight weeks
Tumor response was evaluated by RECIST 1.1. The relationship between DPD activity and the objective tumor response will be evaluated by Cox's proportional hazards regression model.
次要结局
- Overall survival(Three year)
- Progress-free survival(one year)
- Adverse event incidence(One year)