PIPAC and Surgery for Stomach Cancer
(EPICURE Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Odense University Hospital

No Placebo Group

Prior Safety Data

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.

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

Able and willing to provide written informed consent and to comply with the clinical study protocol

I am fully active or can carry out light work.

My cancer can be of any grade.

+10 more

Exclusion Criteria

I am allergic to cisplatin, doxorubicin, or similar drugs.

My kidney function is reduced, with a GFR less than 40 ml/min.

I have severe heart problems that limit my daily activities.

+3 more

Participant Groups

The study tests if PIPAC therapy after minimally invasive stomach cancer surgery improves disease-free survival at one year compared to standard treatment. Patients will receive PIPAC immediately after surgery and again after 6-8 weeks.

2Treatment groups

Experimental Treatment

Active Control

Group I: Pressurized intraperitoneal chemotherapy (PIPAC)Experimental Treatment2 Interventions

In the intervention arm, conventional pressurized intraperitoneal chemotherapy (PIPAC) with cisplatin (10.5 mg/m2 body surface in 150ml saline) and doxorubicin (2.1 mg/m2 body surface in 50ml saline) is performed through Medical Device Regulation (MDR) class IIb the CE-certified nebuliser by certified PIPAC surgeons directly after the completion of the minimally invasive gastric resection and reconstruction using the remaining relevant ports. Chemotherapy is administered through a CE-certified nebulizer according to the manufacturer's manual and followed by 30 minutes of simple diffusion. The carbondioxide is evacuated through a closed system, and the abdominal wall is closed according to local surgical standards. The same procedure is repeated, incorporating the same compounds and dose regimens six to eight weeks postoperatively and before the start of the adjuvant part of the perioperative systemic chemotherapy.

Group II: StandardActive Control1 Intervention

In the control arm, patients will undergo minimally invasive D2 gastrectomy