The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients.
EPICURE
The Efficacy of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) Combined With CURativE Intent Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients. A Multicentre, Randomised, Open-label Phase-II Study
1 other identifier
interventional
264
5 countries
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Sep 2024
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
March 6, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
March 6, 2024
March 1, 2024
2.3 years
February 19, 2024
March 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peritoneal disease-free survival
Peritoneal disease-free survival (P-DFS) defined as no signs of peritoneal recurrence on (PET) CT and/or control laparoscopy with at least 12 months follow-up after minimally invasive D2-gastrectomy
12 months
Secondary Outcomes (10)
Disease-free survival
12 months
Overall survival
12 months
Length of stay
30 days
Postoperative toxicity
30 days
Postoperative complications
30 days
- +5 more secondary outcomes
Study Arms (2)
Pressurized intraperitoneal chemotherapy (PIPAC)
EXPERIMENTALIn 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.
Standard
NO INTERVENTIONIn the control arm, patients will undergo minimally invasive D2 gastrectomy
Interventions
10.5 mg/m2 body surface in 150ml saline
2.1 mg/m2 body surface in 50ml saline
Eligibility Criteria
You may qualify if:
- Gastric or Gastroesophageal junction Siewert type III adenocarcinomas
- Clinical T3-4a-stages
- Any differentiation grade
- Any histological subtype
- Clinical T2-stage
- a. If poorly differentiated or of the poorly cohesive histological subtype, with or without the presence of signet-ring cells
- Any clinical T-stage with positivity for malignant cells on abdominal lavage cytology, which is converted to cytology negative in response to neoadjuvant chemotherapy.
- Any clinical nodal-stage
- clinical M0-stage (positive abdominal wash cytology, which is converted to cytology negative in response to neoadjuvant therapy, is permitted)
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- Age 18 - 80 years
- Undergoing robotic or laparoscopic D2 gastrectomy
- Able and willing to provide written informed consent and to comply with the clinical study protocol
You may not qualify if:
- Previous allergic reaction to cisplatin, doxorubicin or other platinum-containing compounds.
- Renal impairment, defined as glomerular filtration rate (GFR) \< 40 ml/min (Cockcroft-Gault Equation).
- Myocardial insufficiency, defined as New York Heart Association (NYHA) class 3-4.
- An impaired liver function, defined as bilirubin ≥ 1.5 x upper normal limit (UNL).
- An inadequate haematological function, defined as absolute neutrophil count (ANC) \<1.5 x 109/l and platelets \<100 x 109/l.
- Any other condition or therapy which, in the investigator's opinion, may pose a risk to the patient or interfere with the study objectives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Karolinska University Hospitalcollaborator
Study Sites (5)
City of Hope
Duarte, California, 91010, United States
Odense University Hospital
Odense C, 5000, Denmark
University Hospital Lille
Lille, France
Charité, University of Berlin
Berlin, Germany
Karolinska University Hospital
Stockholm, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Bau Mortensen, DMSci, PhD
University of Southern Denmark (sdu.dk)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2024
First Posted
March 6, 2024
Study Start
September 1, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
March 6, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share