NCT03618758

Intraperitoneal Paclitaxel Plus Systemic mFOLFOX6

Safety and Efficacy of Intraperitoneal Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis Receiving Systemic Chemotherapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

Treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. The median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. Intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in Japan, and are showing promising results. This is Korea's first clinical trial on Intraperitoneal Paclitaxel with Systemic mFOLFOX6 chemotherapy.

Conditions

• Gastric Cancer Stage IV
• Peritoneal Carcinomatosis
• Intraperitoneal Paclitaxel
• mFOLFOX6

Interventions

Type	Name	Description
DRUG	Paclitaxel	Intraperitoneal application of Paclitaxel Phase 1: Dose determination of Paclitaxel (Recommended Dose) Starting from 40mg/m² upto 100mg/m² maximum Phase 2: Intraperitoneal Paclitaxel with recommended dose
DRUG	mFOLFOX6 regimen	Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)

Timeline

• Start date: 2018-12-24
• Primary completion: 2023-08-31
• Completion: 2023-12-02
• First posted: 2018-08-07
• Last updated: 2023-12-05

Locations

1 site across 1 country: South Korea