RecruitingACTRN12618001017213

The Safety And Feasibility of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) in the treatment of Unresectable Disseminated Peritoneal Malignancy


Sponsor

Department of Surgery, University of Adelaide, TQEH

Enrollment

112 participants

Start Date

May 20, 2020

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Some cancers spread to the lining of the abdominal cavity (called peritoneal carcinomatosis), and once this happens, standard chemotherapy given through a drip into a vein often can't reach the affected area effectively. This study is testing a specialised technique called PIPAC — Pressurised Intraperitoneal Aerosol Chemotherapy — where chemotherapy is converted into a fine mist and administered directly inside the abdomen during a keyhole surgical procedure. Because the drug is delivered exactly where the cancer is, rather than circulating through the whole body, it may be more effective and cause fewer systemic side effects. This study will assess whether PIPAC is safe, whether it shrinks or stabilises the cancer, and how it affects quality of life in patients whose cancer has stopped responding to standard treatment. You may be eligible if you are 18 or older and have peritoneal carcinomatosis from gastric, pancreatic, appendix, or colorectal cancer that has not responded to standard chemotherapy and cannot be surgically removed. People with bowel obstruction, recent cancer treatment (within four weeks), pregnancy, severe organ dysfunction, or large amounts of abdominal fluid are not eligible.

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 standar

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)

The Queen Elizabeth Hospital - Woodville

SA, Australia

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