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

Part of paid clinical trials in Duarte, California.

Sponsor
Odense University Hospital
Study ID
NCT06295094
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    10.5 mg/m2 body surface in 150ml saline
  • Doxorubicin — DRUG
    2.1 mg/m2 body surface in 50ml saline

Study Details

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.

Key Dates

Start date
Sep 30, 2024
Status verified
Mar 2024
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Pressurized intraperitoneal chemotherapy (PIPAC)
    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.
  • No Intervention: Standard
    In the control arm, patients will undergo minimally invasive D2 gastrectomy

Primary Outcome Measure

Peritoneal disease-free survival [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Yanghee Woo, PhD
[email protected]

Find similar trials in Duarte, CA

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
City of Hope· Duarte, CA

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