Proof of concept: can pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-O) be added to standard treatment for resectable high-risk gastric cancer patients?
- Conditions
- Gastric cancerCancer - Stomach
- Registration Number
- ACTRN12620001228976
- Lead Sponsor
- The Queen Elizabeth Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 10
•Adult patients (> 18 years of age)
•Clinical and histopathological confirmation of gastric adenocarcinoma.
•Undergoing or recommended for curative treatment for gastric adenocarcinoma
•One or more of the following oncological high-risk features must be present:
•Positive cytology in initial peritoneal lavage
•Signet cell ring pathology
•Diffuse type gastric adenocarcinoma
•Linitis plastica as per laparoscopic, endoscopic or imaging assessment
•Proximal location
•Serosal involvement of the stomach (T3/4)
•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 and established and proven peritoneal meatstatic disease.
•Bowel obstruction requiring nasogastric tube or percutaneous endoscopic gastrostomy
•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
•Pregnancy/breast feeding
•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 The primary endpoint is for the consented 10 patients to complete the protocol with no impact on oncological surgical procedure (complications noted in operative report), surgical morbidity (hospital records during recovery period) and adhering to the gold standard FLOT pathway without delays or compromising the timelines (calendar). Formally assessed at 36 weeks, after treament envelope is complete. As this is pilot study, we will undertake a composite, pragmatic approach to assessing the primary outcome. <br>Hospital records will be used for assessment. <br>[36 weeks.]
- Secondary Outcome Measures
Name Time Method Toxicity - blood tests, clinical review[Week 17]