PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer

• Status: Not yet recruiting
• Trial end date: 2027-10-31
• Target enrollment: 0
• Participant gender: All

Summary

Peritoneum is among the most common sites of metastases in gastric cancer. Systemic chemotherapy is the current standard for peritoneal carcinomatosis (PC), although, the treatment results remain extremely poor. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a modern treatment modality for PC, that 1) optimize the drug distribution by applying an aerosol rather than a liquid solution; and 2) apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target. Despite some encouraging preliminary results for PIPAC efficacy, it is still an investigational treatment. Furthermore, only very limited data exist for bidirectional treatment, which includes a combination of systemic chemotherapy and PIPAC. Thus, this study will investigate the feasibility of PIPAC and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vilnius University
• Collaborators: National Cancer Institute (NCI); Vilnius University Hospital Santaros Klinikos
• Treatments: Doxorubicin

Criteria

Inclusion Criteria:

1. Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis;

2. Age≥18;

3. ECOG≤1;

4. Patient willing to participate;

5. Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy.

Exclusion Criteria:

1. Extra-abdominal metastases;

2. Siewert I type gastroesophageal junction cancer;

3. Mechanical bowel obstruction;

4. Allergy to study drugs;

5. History of previous intraperitoneal chemotherapy;

6. Pregnancy of refusal for birth-control at least 6 months post-study treatment