PIPAC and Surgery for Stomach Cancer
(EPICURE Trial)
Trial Summary
What is the purpose of this trial?
The goal of this randomized clinical trial is to investigate whether pressurized intraperitoneal chemotherapy (PIPAC), delivered immediately after minimally invasive D2 gastrectomy and repeated 6-8 weeks later, improves 12-month peritoneal disease-free survival in patients with high-risk gastric adenocarcinoma when compared to standard treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of this treatment for stomach cancer?
Research shows that cisplatin, when used in combination with other drugs like doxorubicin, has been effective in increasing the resection rates (surgical removal of cancer) for stomach cancer. Additionally, studies have found that combinations including cisplatin and doxorubicin can be more effective than some other standard treatments for advanced gastric cancer.12345
Is the treatment with Cisplatin and Doxorubicin generally safe for humans?
Cisplatin can cause kidney damage, hearing loss, and blood-related issues like anemia and low white blood cell counts. Doxorubicin is not specifically mentioned in the provided research, but it is known to have its own side effects, including heart-related issues. It's important to discuss these risks with your doctor.678910
How does PIPAC differ from other treatments for stomach cancer?
PIPAC (pressurized intraperitoneal aerosol chemotherapy) is unique because it delivers chemotherapy directly into the abdominal cavity as a pressurized aerosol, which can improve the local availability of the drugs compared to traditional methods. This approach is particularly useful for treating peritoneal metastases, where cancer has spread to the lining of the abdomen, and may offer an option for patients who are not candidates for more aggressive surgeries.1112131415
Research Team
Michael Bau Mortensen, DMSci, PhD
Principal Investigator
University of Southern Denmark (sdu.dk)
Eligibility Criteria
This trial is for adults aged 18-80 with high-risk gastric cancer who can undergo minimally invasive surgery and are in good physical condition (ECOG 0-1). They must not have had allergic reactions to the chemotherapy drugs being tested, nor should they have severe heart, liver, or kidney problems. Women of childbearing age need a negative pregnancy test and must use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial PIPAC Treatment
Participants undergo minimally invasive D2 gastrectomy followed by pressurized intraperitoneal chemotherapy (PIPAC) with cisplatin and doxorubicin
Second PIPAC Treatment
The PIPAC procedure is repeated 6-8 weeks postoperatively before the start of adjuvant systemic chemotherapy
Follow-up
Participants are monitored for peritoneal disease-free survival and other outcomes with at least 12 months follow-up
Treatment Details
Interventions
- Cisplatin
- Doxorubicin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Odense University Hospital
Lead Sponsor
Karolinska University Hospital
Collaborator