JPRN-jRCTs061200027招募中2 期
Open-label, non-randomized study to evaluate efficacy and safety of intraperitoneal and intravenous paclitaxel plus S-1 in patients with recurrence of gastric cancer with peritoneal dissemination
Fujihara Yoshiyuki0 个研究点目标入组 20 人开始时间: 2020年11月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 85age old（—）
- 性别
- All
入选标准
- •1) Patients whose peritoneal dissemination was confirmed by image diagnosis or examination laparoscopy after radical resection (R0) for gastric adenocarcinoma.
- •2) Patients with following adequate function of important organs at screening period.
- •a) Neutrocyte >= 1,000/mm3
- •b) Hemoglobin >= 8.0g/dl
- •c) Platelet >= 75,000/mm3
- •d) AST, ALT < 100U/L
- •e) Total Bilirubin <= 2.0mg/dL
- •f) Creatinine clearance >= 30ml/min
- •3) ECOG PS with 0-2.
- •4) Age >= 20, < 85 years at consent form.
排除标准
- •1) Patinets with absence of metastasis to distant organ sites except ovary.
- •2) Patients who are contraindicated for S-1 or paclitaxel.
- •3) Patients with experience of using taxane anticancer drugs for unresectable/Recurrent gastric cancer.
- •4) Patients with peritoneal recurrence within 3 months after S-1 adjuvant chemotherapy.
- •5) Patients with concurrent double cancer at registration.
- •6) Patients with serious complications.
- •7) Patients with pregnancy, breast feeding or intention to become pregnant.
- •8) Patients who participated in other clinical studies within 3 months before registration.
研究者
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