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.

Fondazione IRCCS Istituto Nazionale Dei Tumori0 个研究点目标入组 30 人开始时间: 2024年4月23日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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);, age >18;, performance status 2 according to the WHO score, willingness to start adjuvant s-CT and post-operative follow-up, Signing of informed consent.

•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); 3. 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

发起方