Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis

Phase 1

• Conditions: Peritoneal Metastases; Stomach Neoplasm
• Interventions: Procedure: Pressurized Intraperitoneal Aerosol Chemotherapy

• Registration Number: NCT04913662
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with peritoneal metastasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-26
• Study First Submitted: 2021-04-26
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-01
• Last Update Submitted: 2021-06-01
• Study First Posted: 2021-06-04
• Last Update Posted: 2021-06-04
• Primary Completion: 2022-04-26
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Pathologically diagnosed as gastric adenocarcinoma
• Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis
• HER-2 negative tumor
• Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)
• Absolute Neutrophil Count: ≧ 1,500/mm³
• Hemoglobin level: ≧ 8.0g/dL
• Platelet Count: ≧ 10×104/mm³
• AST (GOT), ALT (GPT): ≦ 100U/L
• Total Bilirubin: ≦ 2.0mg/dL
• Creatinine Clearance (CCl): ≧ 50mL/min
• ECOG 0 - 2

Exclusion Criteria

• Patients with other major medical disease or malignant tumors other than gastric cancer
• Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
• Pregnant, breast-feeding women or with birth plan
• History of gastrointestinal surgery
• Patients refusing treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PIPAC Paclitaxel with FOLFOX	Pressurized Intraperitoneal Aerosol Chemotherapy	PIPAC (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)

Primary Outcome Measures

Name	Time	Method
Recommended dose	Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)	Recommended dose of paclitaxel for a phase II trial

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of