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 人开始时间: 2017年8月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
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
- •10. Written informed consent
- •Importantly, enrolment is allowed for patients with an unresected primary tumour (if asymptomatic) and for patients in various lines of palliative treatment, including patients who refuse, have not had, or do not qualify for first-line palliative systemic therapy. All potentially eligible patients are discussed in a multidisciplinary team. Enrolled patients need to be informed about the potential consequences of postponing or discontinuing standard palliative treatment by a medical oncologist prior to enrolment.
- •Previous inclusion criteria:
- •1. Histologically confirmed unresectable peritoneal metastases of a colorectal or appendiceal carcinoma
- •2. Asymptomatic presentation (i.e. no disabling malignant ascites or obstructive symptoms)
- •3. WHO performance score 0-1
- •4. Written informed consent
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
- •8. Enrolment in another clinical study
研究者
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