NCT00180960终止2 期
Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To study overall survival
研究概览
简要总结
The purpose of this study is to evaluate the treatment of a cancerous disease of the peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using oxaliplatin plus irinotecan.
This is a Phase II study with 100 patients. Origins of the tumors: these include colon, rectum, appendix, peritoneum, and endocrine tumors.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peritoneal seedings coming from colon, rectum, pseudomyxoma (appendix), peritoneum (mesothelioma and serous tumors), or endocrine tumors.
- •No extra-abdominal metastases
- •Good general status (American Society of Anesthesiologists Physical Status score [ASA] 1 or 2)
- •Signed consent
排除标准
- •Tumor seedings coming from other origins
- •Huge peritoneal carcinomatosis (peritoneal score > 25, except for pseudomyxomas)
- •Peritoneal carcinomatosis progressing rapidly
- •Presence of extra-abdominal metastases
- •Patients presenting contraindications to the use of oxaliplatin or irinotecan
结局指标
主要结局
To study overall survival
次要结局
- To study mortality-morbidity
研究者
研究点 (2)
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