The Safety And Feasibility of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) in the treatment of Unresectable Disseminated Peritoneal Malignancy
- Conditions
- Peritoneal MetastasesCancer - Other cancer types
- Registration Number
- ACTRN12618001017213
- Lead Sponsor
- Department of Surgery, University of Adelaide, TQEH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 112
•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.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method