← Back to Search

Pressurized intraperitoneal chemotherapy (PIPAC) for Adjuvant Chemotherapy (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

EPICURE Trial 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.Check my eligibility

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.See study design

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.

EPICURE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Peritoneal disease-free survival

Secondary outcome measures

Disease-free survival

Length of stay

Number of patients not receiving adjuvant chemotherapy

+6 more

EPICURE 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

Doxorubicin

2012

Completed Phase 3

~7940

Cisplatin

2013

Completed Phase 3

~1940

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Karolinska University HospitalOTHER

477 Previous Clinical Trials

1,304,934 Total Patients Enrolled

Odense University HospitalLead Sponsor

754 Previous Clinical Trials

1,168,662 Total Patients Enrolled

Michael Bau Mortensen, DMSci, PhDStudy DirectorUniversity of Southern Denmark (sdu.dk)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many locations is this trial currently being conducted?

"Enrollment for this research includes City of Hope in Duarte, Odense University Hospital in Odense C, and Karolinska University Hospital in Stockholm among 5 additional sites."

Answered by AI

Are individuals older than 25 years old being enrolled in this research project?

"Individuals aged 18 years and older up to 80 years are eligible for participation in this clinical trial."

Answered by AI

Is this clinical trial currently open for enrollment?

"As per clinicaltrials.gov, the current status of this research study does not involve participant recruitment. Originally registered on September 1st, 2024, with the latest update made on March 5th, 2024. While this particular trial is inactive in terms of enrollment presently, it's worth noting that there are approximately 660 other ongoing trials actively seeking candidates for participation."

Answered by AI

What are the safety considerations associated with Pressurized intraperitoneal chemotherapy (PIPAC) in patients?

"Based on our assessment at Power, the safety rating for Pressurized intraperitoneal chemotherapy (PIPAC) is a 2. This score reflects the current Phase 2 trial status with available safety data but lacking efficacy evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.

2024. "The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06295094.

All > Gastric Cancer