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. - CRC-PIPAC-II

Catharina Ziekenhuis0 个研究点目标入组 20 人开始时间: 2019年10月8日最近更新: 2020年2月1日

适应症

试验速览

暂无简介。

•- 18 years or older
•- Histologically confirmed PM from a colorectal (including appendiceal) carcinoma that are not amenable for complete cytoreductive surgery, as determined by laparotomy, laparoscopy or radiology.
•- WHO performance score of 0-1
•- Written informed consent
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•-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).

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