None listed
Conditions
Brief 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.
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 a
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.
Sponsors
Department of Surgery, University of Adelaide, TQEH
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adult patients (> 18 years of age) • Clinical confirmation of peritoneal carcinomatosis from gastric, pancreatic, appendiceal or colorectal cancer. • Previous histopathological evidence of neoplastic disease is available. • Patients must have demonstrated resistance to or lack of response to already approved and available systemic chemotherapy. • Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Exclusion criteria
• Extra-abdominal metastatic disease, excluding low volume lung metastasis. • Bowel obstruction requiring nasogastric tube or percutaneous endoscopic gastrostomy • Chemotherapy, radiotherapy or surgery within the last 4 weeks prior to dosing • History of allergic reaction to platinum containing compounds or doxorubicin • Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias • Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system • Large volume ascites (greater than one litre). • Pregnancy • Any chronic medical or psychiatric condition that in the option of the investigators would make the subject unsuitable for the study or prevent compliance with study protocol procedures.
Outcome results
None listed