NCT02528110

Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer During Radical Gastrectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Wuhan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.

Detailed description

To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) and are followed up for 5 years or until death. The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Conditions

• Malignant Neoplasm of Stomach

Interventions

Type	Name	Description
PROCEDURE	Hyperthermic intraperitoneal chemotherapy (HIPEC)	Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
PROCEDURE	D2 radical gastrectomy	radical gastrectomy with D2 lymphadenectomy
OTHER	SOX postoperative chemotherapy	Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
OTHER	XELOX postoperative chemotherapy	Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-03-10
• Completion: 2020-03-10
• First posted: 2015-08-19
• Last updated: 2020-03-24

Locations

1 site across 1 country: China