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

Wuhan University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Malignant Neoplasm of Stomach

Interventions

Hyperthermic intraperitoneal chemotherapy (HIPEC)PROCEDURE

Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.

D2 radical gastrectomyPROCEDURE

radical gastrectomy with D2 lymphadenectomy

SOX postoperative chemotherapyOTHER

Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histological proved diagnosis of locally advanced gastric cancer. * No evidence of distant metastases or peritoneal metastases. * Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage. * Eligible for radical gastrectomy with D2 lymphadenectomy. * Have not received cytotoxic chemotherapy or radiotherapy. * Written informed consent is obtained prior to commencement of trial treatment. Exclusion Criteria: * Existence of distant metastasis or peritoneal metastasis during surgery (M1). * Any previous chemotherapy or radiotherapy * Active systemic infections * Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * Female patients who are pregnant or breast feeding

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Outcomes

Primary Outcomes

overall survival

From the date of surgery to the date of death or to the end of follow-up

Time frame: 5 years

Secondary Outcomes

progression-free survival

Time frame: 5 years

distant metastasis rate

Time frame: 5 years

peritoneal metastasis rate

Time frame: 5 years

local recurrence rate

Time frame: 5 years

complication rate

Time frame: 5 years

Data from ClinicalTrials.gov

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