Proof of concept: can pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-O) be added to standard treatment for resectable high-risk gastric cancer patients?

Feasibility of adding pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-O) to standard treatment for resectable high-risk gastric cancer patients

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001228976

Enrollment

Registered

2020-11-17

Start date

2020-12-01

Completion date

2021-08-02

Last updated

2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine the possibility of adding a one-time PIPAC procedure (spraying chemotherapy drug into the abdomen) to the standard treatment of gastric cancer Who is it for? You may be eligible for this study if you are aged 18 years or older, with diagnosis of gastric adenocarcinoma and undergoing or being recommended for the standard treatment. Study details Participants in this study will undergo a procedure with a camera is inserted into the abdomen to check for metastatic disease. During this procedure, chemotherapy drug will be sprayed into the abdominal cavity. The patient will spend one night in hospital for observation and be discharged home in the morning. Participants will be expected to complete some assessments. Assessments will include clinic visits and quality of life questionnaires. It is hoped that this research will help to determine whether patients will be able to tolerate the additional the standard of care regime without increased toxicity or a need to spend more than one extra day of time in hospital.

Interventions

Oxaliplatin dose is 92 mg/m2 constituted in 150 ml dextrose. This will be delivered via Capnopen during the procedure. This is a one time intervention.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Outcome results