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PIPAC and Surgery for Stomach Cancer (EPICURE Trial)

Phase 2

Waitlist Available

Research Sponsored by Odense University Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using a specific type of chemotherapy called pressurized intraperitoneal chemotherapy (PIPAC) right after minimally invasive D2 gastrectomy surgery, and again

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include those common to chemotherapy such as nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood cell counts, kidney issues from Cisplatin and heart complications from Doxorubicin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peritoneal disease-free survival

Secondary study objectives

Disease-free survival

Length of stay

Number of patients not receiving adjuvant chemotherapy

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Doxorubicin

2012