EUCTR2015-005695-15-NL进行中（未招募）1 期
Treatment of PERitoneal dissemination in Stomach Cancer patients with cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the PERISCOPE II study - PERISCOPE II-study
KI-AV0 个研究点目标入组 226 人开始时间: 2016年11月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 226
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age = 18 years
- •- cT3-cT4 adenocarcinoma (or undifferentiated carcinoma) of the stomach, considered to be resectable
- •- Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal cytology (proven by laparoscopy or laparotomy)
- •- Absence of disease progression during prior systemic chemotherapy
- •- WHO performance status 0-2
- •- Adequate bone marrow, hepatic and renal function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •- Distant metastases or small bowel dissemination
- •- Recurrent gastric cancer
- •- Prior resection of the primary gastric tumour
- •- Non-synchronous peritoneal carcinomatosis
- •- Current other malignancy (other than cervix carcinoma and basalioma)
- •- Hepatitis B or C, known HIV infection or an uncontrolled infectious disease
- •- Recent myocardial infarction (< 6 months) or unstable angina
- •- Uncontrolled diabetes mellitus
- •- Pregnancy or breast feeding
- •- Any medical condition that is considered to interfere with study procedures and/or would jeopardize safe treatment
- •- Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
研究者
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