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

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

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

Sponsors & Collaborators

• National Cancer Center, Korea

  collaborator OTHER_GOV

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Yeungnam University Hospital

  collaborator OTHER

• Daegu Catholic University Medical Center

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Dong-A University Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Korea Cancer Center Hospital

  collaborator OTHER

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  collaborator OTHER

• Hanyang University

  collaborator OTHER

• Kyungpook National University Hospital

  lead OTHER

Principal Investigators

• Wansik Yu, MD. PhD · Kyungpook National University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2015-12-31

Completion

2018-11-30

Countries

• South Korea

Study Locations