NCT00512681已完成2 期
A Phase II Study of S-1 Combined With Irinotecan and Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Maximal overall response rate
研究概览
简要总结
Patients will be treated with irinotecan (150mg/m2) followed by oxaliplatin (85mg/m2)on day 1 and S-1(80mg/m2/day) from day 1 to 14 every 3 weeks. Patients will receive up to a planned treatment of maximum 12 cycles of chemotherapy. Response assessement will be performed every 2 cycles of chemotherapy.
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 gastric adenocarcinoma with recurrent or metastatic disease
- •Age ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Disease status must be that of measurable disease as defined by RECIST criteria:Measurable lesions: Lesions that can be accurately measured in at least one dimension by any of the following: - CT of abdomen, pelvis or thorax, if the longest diameter to be recorded is at least 10 mm with spiral CT- Chest x-ray, if the lung lesion to be recorded is clearly defined and surrounded by aerated lung and the diameter to be recorded is at least 20 mm- Physical examination, if the clinically detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm
- •No prior treatment for recurrent or metastatic disease; prior adjuvant/neoadjuvant therapy is allowed if at least 12 months have elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study. However, prior oxaliplatin and/or irinotecan as adjuvant therapy are not allowed.
- •Adequate major organ function including the following: Hematopoietic function: ANC ³ 1,500/mm3, Platelet ³ 100,000/mm3Hepatic function: serum bilirubin 1.5 mg/dl, AST/ALT levels 2.5 x UNL ( 5 x UNL if liver metastases are present)Renal function: serum creatinine UNL
- •Patients should sign a written informed consent before study entry
排除标准
- •Prior history of peripheral neuropathy
- •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
结局指标
主要结局
Maximal overall response rate
时间窗: During chemotherapy
次要结局
- Progression-free survival,Overall survival,Toxicity assessment,&genetic polymorphism and association with chemical outcomes(during study period)
研究者
研究点 (2)
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