ACTRN12620001228976尚未招募1 期
Feasibility of adding pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-O) to standard treatment for resectable high-risk gastric cancer patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Adult patients (> 18 years of age)
- •Clinical and histopathological confirmation of gastric adenocarcinoma.
- •Undergoing or recommended for curative treatment for gastric adenocarcinoma
- •One or more of the following oncological high-risk features must be present:
- •Positive cytology in initial peritoneal lavage
- •Signet cell ring pathology
- •Diffuse type gastric adenocarcinoma
- •Linitis plastica as per laparoscopic, endoscopic or imaging assessment
- •Proximal location
- •Serosal involvement of the stomach (T3/4)
- •Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
排除标准
- •Extra-abdominal metastatic disease and established and proven peritoneal meatstatic disease.
- •Bowel obstruction requiring nasogastric tube or percutaneous endoscopic gastrostomy
- •History of allergic reaction to platinum containing compounds or doxorubicin
- •Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias
- •Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system
- •Pregnancy/breast feeding
- •Any chronic medical or psychiatric condition that in the option of the investigators would make the subject unsuitable for the study or prevent compliance with study protocol procedures.
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