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

NCT06295094 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

  • Gastric Cancer
  • Chemotherapy, Adjuvant
  • Peritoneal Metastases
  • Minimally Invasive Surgical Procedures

Interventions

DRUG

Cisplatin

10.5 mg/m2 body surface in 150ml saline

DRUG

Doxorubicin

2.1 mg/m2 body surface in 50ml saline

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Michael Bau Mortensen, DMSci, PhD · University of Southern Denmark (sdu.dk)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2027-01-31
Completion
2028-01-31

Countries

  • United States
  • Denmark
  • France
  • Germany
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06295094 on ClinicalTrials.gov