NL-OMON28502招募中不适用
Bidirectional treatment consisting of repetitive laparoscopic electrostatic pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) and systemic intravenous chemotherapy for isolated unresectable colorectal peritoneal metastases: feasibility, safety, tolerability, and preliminary efficacy.
The Catharina Hospital Eindhoven, the Netherlands & the St. Antonius Hospital Nieuwegein, the Netherlands0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 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
入选标准
- •18 years or older;
- •- Histologically confirmed PM from a colorectal (including appendix) carcinoma that are not amenable for complete cytoreductive surgery, determined by radiology, laparotomy or laparoscopy;
- •- WHO performance score of 0-1 and life expectancy >3 months;
- •- Written informed consent;
排除标准
- •- Radiological evidence of systemic metastatic disease (e.g. liver, lung);
- •- Symptomatic presentation (e.g. non-deviated obstructive symptoms);
- •- Histologically confirmed PM from a low grade appendiceal carcinoma (Disseminated Peritoneal Adeno-Mucinosis / Low-grade Appendiceal Mucinous Neoplasm);
- •- Inadequate organ functions, defined as an Hb of <5.0 mmol/L, an absolute neutrophil count of <1.5 x 10^9/L, platelet count of <100 x 10^9/L, serum creatinine of >1.5 x ULN, creatinine clearance (Cockroft formula) of <30 ml/min, and liver transaminases of >5 x ULN;
- •- Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, uncompensated cardiac disease, coagulopathy, serious active infections), as determined by the medical oncologist;
- •- Any contraindication for a laparoscopy, as determined by the surgeon and/or anesthesiologist;
- •- Previous PIPAC-procedures;
- •- Previous treatment with palliative systemic chemotherapy (Note: this criterium does not include patients that received systemic chemotherapy in a (neo-)adjuvant setting. (neo-)adjuvant systemic chemotherapy has to be administered >6 months before trial inclusion to be eligible for trial participation).
研究者
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