NCT00209664暂停2 期
Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0303
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- objective tumor response
研究概览
简要总结
To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative gastric cancer
详细描述
A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV gastric cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •・ Eligibility criteria
- •Histological diagnosis of gastric adenocarcinoma.
- •Measurable or assessable lesions.
- •Age: 18 ~ 75 years.
- •Performance Status (ECOG): 0 ~
- •No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
- •No history of treatment with CPT-11 or S-
- •No history of radiotherapy to the abdomen.
- •Oral intake of S-1 is possible.
- •Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm
- •Hb 10.0 g/dl. Platelet count 100,000/mm
- •GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes). (10) Predicted survival for >3 months.
- •(11) Able to give written informed consent
排除标准
- 未提供
结局指标
主要结局
objective tumor response
次要结局
- Response duration, time to progression, median survival time, and safety will also be assessed.
研究者
研究点 (2)
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