EUCTR2017-000927-29-NL进行中（未招募）1 期
Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a multicentre, open-label, single-arm, phase II study (CRC-PIPAC) - CRC-PIPAC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
入选标准
- •Eligible patients are adults who have:
- •? a World Health Organisation (WHO) performance status of =1 and life expectancy >3 months;
- •? histological or cytological proof of PM of a colorectal or appendiceal carcinoma;
- •? unresectable disease determined by abdominal computed tomography (CT) and a diagnos-tic laparoscopy or laparotomy; .
- •? 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 trans-aminsases <5 x ULN);
- •? no symptoms of gastrointestinal obstruction;
- •? no radiological evidence of systemic metastases;
- •? no contraindications for oxaliplatin or 5-fluorouracil/leucovorin;
- •? no contraindications for a laparoscopy; ? no previous PIPAC-procedures;
- •? 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 multidisplinary 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.
- •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 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •See inclusion criteria
研究者
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