NCT02205008

Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer

Prospective Randomized Multicenter Phase III Trial of Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Kyungpook National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal chemotherapy have been published. In this study, we review the clinicopathological characteristics of patients and effects of early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric cancer-specific survival and patterns of recurrence of gastric cancer patients with macroscopic serosal invasion. The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall and disease free survival of advanced gastric cancer patients with serosal invasion after potentially curative surgery.

Conditions

• Advanced Gastric Cancer With Serosal Invasion

Interventions

Type	Name	Description
PROCEDURE	surgery	Total or subtotal gastrectomy with D2
DRUG	adjuvant systemic chemotherapy	adjuvant systemic chemotherapy with S-1 (\<1.25m2:40mg, 1.25-1.5m2:50mg, \>1.5m2:60mg, bid)
DRUG	Early postoperative intraperitoneal chemothgerapy	operation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2 1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-12-01
• Completion: 2018-11-01
• First posted: 2014-07-31
• Last updated: 2014-07-31

Locations

1 site across 1 country: South Korea