ISRCTN89947480
已完成
2 期
Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a multicentre, open-label, single-arm, phase II study
Catharina Hospital0 个研究点目标入组 20 人2017年8月14日
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Isolated unresectable colorectal peritoneal metastases
- 发起方
- Catharina Hospital
- 入组人数
- 20
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
2020 protocol in https://pubmed.ncbi.nlm.nih.gov/31352425/ (added 07/08/2020) 2021 results in https://pubmed.ncbi.nlm.nih.gov/32572849/ (added 12/03/2021)
研究者
入排标准
入选标准
- •Current inclusion criteria as of 16/01/2019:
- •1\. A World Health Organisation (WHO) performance status of \=1 and life expectancy \>3 months
- •2\. Histological or cytological proof of PM of a colorectal or appendiceal carcinoma
- •3\. Unresectable disease determined by abdominal computed tomography (CT) and a diagnostic laparoscopy or laparotomy
- •4\. Adequate organ functions (haemoglobin \=5\.0 mmol/L, neutrophils \=1\.5 x 109/L, platelets \=100 x 109/L, serum creatinine \<1\.5 x ULN, creatinine clearance \=30 ml/min, and liver transaminsases \<5 x ULN)
- •5\. No symptoms of gastrointestinal obstruction
- •6\. No radiological evidence of systemic metastases
- •7\. No contraindications for oxaliplatin or 5\-fluorouracil/leucovorin
- •8\. No contraindications for a laparoscopy
- •9\. No previous PIPAC\-procedures
排除标准
- •Current exclusion criteria as of 16/01/2019:
- •See ‘inclusion criteria’
- •Previous exclusion criteria:
- •1\. Radiological evidence of extra\-abdominal metastatic disease
- •2\. Inadequate organ functions (hemoglobin \<5\.0 mmol/L, absolute neutrophil count \<1\.5 x 10(9\)/L, platelet count \<100 x 10(9\)/L, serum creatinine \>1\.5 x ULN, creatinine clearance \<30 ml/min, liver transaminases \>5 x ULN)
- •3\. Known pregnancy or lactation
- •4\. Known unstable or uncompensated respiratory or cardiac disease
- •5\. Known bleeding diathesis or coagulopathy
- •6\. Serious active infections
- •7\. Any other condition not allowing for a safe laparoscopy or a safe administration of oxaliplatin, 5\-fluorouracil, or leucovorin
结局指标
主要结局
未指定
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