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Clinical Trial Summary

Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.


Clinical Trial Description

The objective of the trial is to compare the treatment of patients with advanced gastric cancer without evidence of distant metastases treated with D2 radical gastrectomy and intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients treated with D2 radical gastrectomy alone and postoperative chemotherapy (Group A).

The hypothesis of the trial is that D2 radical gastrectomy with intraperitoneal chemoperfusion (Group B) is superior to D2 radical gastrectomy (Group A) in terms of overall survival.

The trial is designed as a prospective, randomized, open, multicenter and parallel group study. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02381847
Study type Interventional
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact Meng Wang
Phone 86-13815890469
Email wangmeng001@263.net
Status Recruiting
Phase Phase 3
Start date January 2015
Completion date March 2020

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