The Safety And Feasibility of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) in the treatment of Unresectable Disseminated Peritoneal Malignancy
Department of Surgery, University of Adelaide, TQEH
112 participants
May 20, 2020
Interventional
Conditions
Summary
The aim of this study is to assess feasibility, tumour response, adverse events, and quality of life of aerosolised chemotherapy in peritoneal cancer/s Who is it for? You may be eligible for this study if you are ages 18 or above and have clinical confirmation of unresectable peritoneal carcinomatosis from gastric, pancreatic, appendiceal or colorectal cancer Study details This study is for patients who have unresectable peritoneal metastases and have not responded to standard systemic chemotherapy. All eligible patients will receive the intervention. In a operating theatre, your belly/abdomen will have chemotherapy pumped directly into it. This study will involve blood tests, imaging, questionnaires and physical examinations. It is hoped this research will demonstrate the safety and effectiveness of this technique in the management of peritoneal metastases.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
PIPAC is a novel therapeutic approach that is minimally invasive, does not require cytoreduction (laparotomy) and can be frequently repeated. PIPAC entails accessing the abdominal cavity using standard laparoscopic techniques with the chemotherapeutics aerosolized via a high-pressure micro-injection pump. Oxaliplatin (or other standard of care chemotherapy as per Investigator) will be administered at 92 mg/m2 constituted in 150 ml dextrose. Each patient will undergo three cycles, six weeks apart. Injection parameters are a flow of 30mL/min and a maximum upstream pressure of 200 psi. This intervention replaces systemic chemotherapy or palliative chemotherapy.
Locations(1)
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ACTRN12618001017213