NL-OMON50015已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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
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
- •- 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. Patients treated with (neo-)adjuvant chemotherapy are
- •able to enrol in the study if this treatment was finished >6 months before
- •trial enrolment).
研究者
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