NCT00142350已完成3 期
Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 690
- 试验地点
- 68
- 主要终点
- overall survival
研究概览
简要总结
To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer
详细描述
From the results of our previous phase III study (JCOG9205), continuous infusion of 5-fluorouracil has remained to be a control arm of this study. This study investigates the superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall survival, and the planned number of enrolled patients is 690 (230/arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unresectable or recurrent histologically proved gastric cancer
- •adequate oral intake
- •age 20 or older and 75 or younger
- •Performance Status (ECOG):0, 1, 2
- •measurable or unmeasurable lesions
- •preserved organ functions
- •no severe medical condition
- •no prior chemotherapy for gastric cancer
- •written informed consent
排除标准
- •patient with marked infection or inflammation
- •patient with severe peritoneal metastasis
- •patient with massive pleural effusion
- •patient with metastasis to CNS
- •patient with diarrhea 4 or more times per day
- •patient severe medical condition
- •patient with other concurrent malignancy affecting on survival or adverse events
- •pregnant or nursing patient or with intent to bear baby
- •patient evaluated to be inadequate by a attending doctor
- •patient requiring nutritional support
结局指标
主要结局
overall survival
次要结局
- time to treatment failure
- incidences of adverse events
- response rate
- non-hospitalized survival
研究者
研究点 (68)
Loading locations...
相似试验
Unknown
2 期
ILF With/Without Cisplatin for Advanced Gastric CancerStomach NeoplasmNCT00320294Gachon University Gil Medical Center86
已完成
3 期
A Phase III Study Comparing Irinotecan, Cisplatin and Etoposide (PEI) with Nogitecan for the Treatment of Relapsed Small-Cell Lung Cancer (JCOG0605)Sensitive relpased small-cell lung cancerJPRN-UMIN000000828Japan Clinical Oncology Group(JCOG)180
招募中
不适用
A phase II study of Irinotecan and cisplatin combination chemotherapy in metastatic, unresectable esophageal cancerNeoplasmsKCT0000670Seoul National University Hospital23
终止
1 期
Safety Study of the Chemotherapy Modulator PHY906 in Patients With Advanced Colorectal CancerDiarrheaColorectal NeoplasmsNCT00036517PhytoCeutica30
终止
1 期
A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal CancerMetastatic Colorectal CancerNCT00819754Ottawa Hospital Research Institute23