2024-513376-17-00招募中2 期
Phase II study of adjuvant pressurized intraperitoneal aerosol chemotherapy (PIPAC) for the prevention of peritoneal metastases after curative-intent surgery for high-risk colorectal cancer.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The efficacy of adjuvant PIPAC will be assessed by measuring peritoneal metastasis-free survival from the date of primary surgery to the date of MP diagnosis.
研究概览
简要总结
Primary Objective of this study is to demonstrate the effectiveness of adjuvant PIPAC performed within 4-8 weeks after curative-intent surgery, and followed by adjuvant s-CT, in preventing the onset of PM in high risk colon cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histopathological diagnosis of intestinal type, mucinous or signet ring cell adenocarcinoma of the colon (with upper limit of the tumor above peritoneal reflection)
- •Curative (microscopically complete) surgery performed by laparotomy or laparoscopy
- •presence of at least one of the following risk factors for the development of metacrhonous PM: • perforated primary tumor (any T, N0-2b, M0); • primary tumor infiltrating the visceral peritoneum (pT4a, N0-2b, M0), or directly invading adjacent organs (pT4b, N0-2b, M0);
- •performance status 2 according to the WHO score
- •willingness to start adjuvant s-CT and post-operative follow-up
- •Signing of informed consent.
排除标准
- •active sepsis
- •pregnancy or lactation in progress;
- •psychiatric or neurological conditions such as to preclude protocol procedures
- •contraindications to laparoscopy
- •known hypersensitivity to oxaliplatin or other platinum containing compounds and/or to any of their excipients;
- •history of previous malignancies treated in the last three years, excluding cutaneous
- •spinocellular carcinoma and/or basocellular carcinoma; prior pre-operative radio-chemotherapy.
- •cardiac function impairment (history of previous heart failure or 40% FE);
- •renal impairment (serum creatinine >1.5 normal value or creatinine clearance 60 ml/min)
- •liver function impairment (AST, ALT, bilirubin > 1.5 normal value)
- •bone marrow function impairment (leukocytes 4000 / mm3, neutrophils 1500 /mm3, platelets 80000/mm3)
- •lung function impairment (diagnosis of severe COPD or 50% FEV1 or 40% DLCO adjusted for age)
- •renal impairment (serum creatinine >1.5 normal value or creatinine clearance 60 ml/min)
- •extra-abdominal and/or hepatic metastases at the CT scan of the chest, abdomen and pelvis with intravenous contrast;
- •severe complications (grade 3-4) after primary cancer surgery;
- •haemorrhagic diathesis or coagulopathy
结局指标
主要结局
The efficacy of adjuvant PIPAC will be assessed by measuring peritoneal metastasis-free survival from the date of primary surgery to the date of MP diagnosis.
The efficacy of adjuvant PIPAC will be assessed by measuring peritoneal metastasis-free survival from the date of primary surgery to the date of MP diagnosis.
次要结局
未报告次要终点
研究者
Clinical Trials Center
Scientific
Fondazione IRCCS Istituto Nazionale Dei Tumori
研究点 (1)
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