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 (CRC-PIPAC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Major toxicity
研究概览
简要总结
This is multicentre, open-label, single-arm phase II study that investigates the feasibility, safety, tolerability, preliminary efficacy, costs, and pharmacokinetics or repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC-OX) as a palliative monotherapy for patients with isolated unresectable colorectal peritoneal metastases.
详细描述
Rationale: repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) is offered as a palliative treatment option for patients with isolated unresectable colorectal peritoneal metastases (PM) in several centres worldwide. However, little is known about its feasibility, safety, tolerability, efficacy, costs, and pharmacokinetics in this setting.
Objectives: to prospectively explore the feasibility, safety, tolerability, preliminary efficacy, costs, and pharmacokinetic profile of repetitive ePIPAC-OX as a palliative monotherapy for isolated unresectable colorectal PM under controlled circumstances.
Study design: multicentre, open-label, single-arm, phase II study.
Setting: two Dutch tertiary referral hospitals for the surgical treatment of colorectal PM.
Study population: adults who have a World Health Organisation (WHO) performance status of 0 or 1, adequate organ functions, histologically or cytologically confirmed unresectable PM of a colorectal or appendiceal carcinoma, no systemic metastases, no symptoms of gastrointestinal obstruction, no contraindications for the planned intervention, and no previous pressurised intraperitoneal aerosol chemotherapy (PIPAC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients are adults who have:
- •a World Health Organisation (WHO) performance status of ≤1;
- •histological or cytological proof of PM of a colorectal or appendiceal carcinoma;
- •unresectable disease determined by abdominal computed tomography (CT) and a diagnostic 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 transaminases <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.
- •Enrolled patients are excluded from the analyses in case they did not receive a first ePIPAC-OX, e.g.:
- •due to systemic metastases on baseline thoracoabdominal CT, or;
- •due to non-access during first ePIPAC-OX, or;
- •due to resectable disease during first ePIPAC-OX.
- •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 by a multidisciplinary team. Enrolled patients are informed about the potential consequences of postponing or discontinuing standard palliative treatment by a medical oncologist prior to enrolment.
排除标准
- 未提供
研究组 & 干预措施
repetitive ePIPAC-OX
干预措施: repetitive ePIPAC-OX (Combination Product)
结局指标
主要结局
Major toxicity
时间窗: Expected (in case of three ePIPAC-OX): 16 weeks
Number of patients with Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade III-V, up to 4 weeks after the last ePIPAC-OX
次要结局
- Quality of life: QLQ-CR29(Expected (in case of three ePIPAC-OX): 16 weeks)
- Cytological tumour response(Expected (in case of three ePIPAC-OX): 12 weeks)
- Macroscopic tumour response(Expected (in case of three ePIPAC-OX): 12 weeks)
- Minor toxicity(Expected (in case of three ePIPAC-OX): 16 weeks)
- Major postoperative complications(Expected (in case of three ePIPAC-OX): 16 weeks)
- Radiological tumour response(Expected (in case of three ePIPAC-OX): 16 weeks)
- Organ-specific toxicity(Expected (in case of three ePIPAC-OX): 16 weeks)
- Hospital stay(Expected (in case of three ePIPAC-OX): 16 weeks)
- Biochemical tumour response(Expected (in case of three ePIPAC-OX): 16 weeks)
- Pharmacokinetics(Expected (in case of three ePIPAC-OX): 13 weeks)
- Procedure-related characteristics: intraoperative complications(Expected (in case of three ePIPAC-OX): 12 weeks)
- Procedure-related characteristics: adhesions(Expected (in case of three ePIPAC-OX): 12 weeks)
- Minor postoperative complications(Expected (in case of three ePIPAC-OX): 16 weeks)
- Readmissions(Expected (in case of three ePIPAC-OX): 16 weeks)
- Histopathological tumour response(Expected (in case of three ePIPAC-OX): 12 weeks)
- Quality of life: EQ-5D-5L(Expected (in case of three ePIPAC-OX): 16 weeks)
- Quality of life: QLQ-C30(Expected (in case of three ePIPAC-OX): 16 weeks)
- Progression-free survival(24 months)
- Costs(Expected (in case of three ePIPAC-OX): 16 weeks)
- Procedure-related characteristics: operating time(Expected (in case of three ePIPAC-OX): 12 weeks)
- Overall survival(24 months)
- Environmental safety of ePIPAC-OX(1 week (measured only during the first three procedures in the study))
- Procedure-related characteristics: blood loss(Expected (in case of three ePIPAC-OX): 12 weeks)
研究者
Koen Rovers
MD, Coordinating Investigator
Catharina Ziekenhuis Eindhoven