NCT01227239Unknown1 期
A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Phase I: Determine the Recommended dose (RD)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study.
The purpose of this study is as follows,
- In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD).
- In phase II, to evaluate the antitumor effect (pCR rate) and the safety .
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed locally advanced and non-metastatic rectal adenocarcinoma (clinical stage T3, anyN or T4, anyN)
- •Possible to R0 resection
- •Received no prior therapy
- •Performance status (ECOG) 0-1
- •Normal organ and marrow function.
- •Sufficient oral intake
排除标准
- •History of serious allergic reaction
- •Patients without serious complications such as sensory neurotoxicity or serious diarrhea (with watery stool).
- •Female with pregnancy or lactation
- •Have another malignancy in the past 5 years except early stage other cancer that cure by local treatment
研究组 & 干预措施
1
Experimental
干预措施: S-1 (Drug)
1
Experimental
干预措施: Oxaliplatin (Drug)
1
Experimental
干预措施: Radiation (Radiation)
结局指标
主要结局
Phase I: Determine the Recommended dose (RD)
时间窗: 10 weeks
Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels
Phase II: pathological complete response rate
时间窗: 12-16 week
Pathological complete response(pCR) rate is calculated by numbers of pCR cases (grade 3) devided the number of subjected cases.
次要结局
- R0 resection rate(12-16 weeks)
- down staging rate(12-16 weeks)
- local reccurence rate(3 years)
- desease free survuval(3 years)
- safety(16-20 weeks)
研究者
研究点 (6)
Loading locations...
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