NCT00343668Unknown2 期
A Phase II Study of S-1 and Irinotecan Combination Chemotherapy in Patients With Advanced Gastric Cancer as a First-Line Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 44
- 试验地点
- 14
- 主要终点
- response rate
研究概览
简要总结
The primary goal of this phase II trial is to evaluate the response rate of combination chemotherapy with S-1 and Irinotecan in patients with advanced gastric cancer as a first-line therapy.
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
- •Pathologically proven unresectable adenocarcinoma of stomach
- •With uni-dimensionally measurable disease (at least longest diameter 2 cm on conventional CT scan, x-ray or physical examination, or 1cm on spiral CT scan)
- •Age 18 to 70 years old
- •Estimated life expectancy of more than 3 months
- •ECOG performance status of 2 or lower
- •Adequate bone marrow function(absolute neutrophil count [ANC] ≥1,500/µL, hemoglobin ≥9.0 g/dL,and platelets ≥100,000/µL)
- •Adequate kidney function (serum creatinine < 1.5 mg/dL)
- •Adequate liver function (serum total bilirubin < 2 times the upper normal limit (UNL); serum transaminases levels <3 times [<5 times for patients with liver metastasis] UNL)
- •No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. (but, prior adjuvant chemotherapy with capecitabine or S-1 or camptothecin analogues was excluded)
- •No prior radiation therapy for at least 4 weeks before enrollment in the study
排除标准
- •Other tumor type than adenocarcinoma
- •Central nervous system (CNS) metastases or prior radiation for CNS metastases
- •Gastric outlet obstruction or intestinal obstruction
- •Evidence of gastrointestinal bleeding
- •The patient has bony lesions as the sole evaluable disease.
- •Past or concurrent history of neoplasm other than stomach cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
- •Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- •Other serious illness or medical conditions
- •Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
- •History of significant neurologic or psychiatric disorders including dementia or seizures
- •Active uncontrolled infection
- •Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- •Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
- •concomitant drug medication; The following drugs cause drug interaction with S-
- •i. Warfarin, phenprocoumon: increase bleeding tendency ii. Increase blood concentration of phenytoin iii. sorivudine: inhibit DPD -> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of S-1
结局指标
主要结局
response rate
时间窗: best response
次要结局
- treatment-related toxicities(during treatment)
研究者
研究点 (14)
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