NCT00587145Unknown2 期
Phase II Study of Perioperative S-1 Plus Docetaxel in Patients With Localized Advanced Gastric Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- To evaluate the clinical responses to preoperative S-1 plus docetaxel
研究概览
简要总结
This study is an open-label, single center, and a single arm phase II study to evaluate the clinical response and safety of perioperative S-1 plus docetaxel. Perioperative chemotherapy is composed of 3 cycles of preoperative S-1/docetaxel and 3 cycles of postoperative S-1/docetaxel.Chemotherapy regimen:
- S-1 80 mg/m2/day every 12-h p.o. on days 1(evening)-15 (morning)
- Docetaxel 35 mg/m2 mixed in d5w 250 ml iv over 60-min on days 1 and 8
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed localized gastric adenocarcinoma as defined by CT stage III and IV (M0) (but not N3, which is metastatic node in WHO TNM classification), according to Japanese TNM classification system
- •No distant metastatic disease in laparoscopy
- •Age: 18-70 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Disease status must be that of measurable disease as defined by RECIST: Measurable lesions: lesions that can be accurately measured in at least one dimension by abdominal CT, if the longest diameter to be recorded is at least 10 mm with spiral CT
- •Adequate major organ function including the following: Hematopoietic function: WBC ³ 4,000/mm3, ANC ³ 1,500/mm3, Platelet ³ 100,000/mm3Hepatic function: serum bilirubin £ 1.5 mg/dl, AST/ALT levels £ 2.5 x UNLRenal function: serum creatinine £ 1.5 mg/dl
- •Patients should sign a written informed consent before study entry
排除标准
- •CT Stage I, II, M1 or N3, which is metastatic node in WHO TNM classification, according to Japanese TNM classification system
- •Prior chemotherapy or radiotherapy
- •Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
- •Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
- •Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
- •Psychiatric disorder that would preclude compliance
- •Pregnant, nursing women or patients with reproductive potential without contraception
- •Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
结局指标
主要结局
To evaluate the clinical responses to preoperative S-1 plus docetaxel
时间窗: During chemotherapy
次要结局
- the clinical downstaging,the pathologic responses, toxicity profile,the disease-free survival,overall survival,the effect of CYP2A6 genetic polymorphisms on the pharmacokinetics and the difference in pharmacokinetics between before and after gastrectomy(During study period)
研究者
研究点 (2)
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