Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer

Affiliated Cancer Hospital & Institute of Guangzhou Medical University582 enrolled

Overview

The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

582

Conditions

Advanced Gastric Adenocarcinoma

Interventions

D2 lymphadenectomyPROCEDURE

The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.

Systemic chemotherapyPROCEDURE

HIPECPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 \< age ≤ 65 years old * Male or Non pregnant female * The Eastern Cooperative Oncology Group (ECOG) status ≤ 2 * Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan) * Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy * White blood cells \> 4,000/mm3 * neutrophils ≥ 1,500/mm3 * platelets ≥ 100,000/mm3 * hemoglobin\>9g/l * Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< or = 2.5 times upper limit of nominal (ULN) * total bilirubin (TBIL) \< 1.5 times ULN * serum creatinine \< 1 times ULN * Having given written informed consent prior to any procedure related to the study Exclusion Criteria: * Existence of macroscopic peritoneal implants * Prior malignant tumors with detectable signs of recurrence or distant metastasis * Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50% * Receiving other cytotoxic chemotherapy * High grade of intra-abdominal adhesions * Contraindication to any therapy contained in this regimen specific to the study Without given written informed consent

Locations (1)

Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

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

Recurrence-free survival

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

Time frame: 5 years

Locoregional-free survival

From the date of surgery to the date of locoregional recurrence or to the end of follow-up

Time frame: 5 years

Hepatic metastases-free survival

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

Time frame: 5 years

Central Contacts

zhiyuan fang, Ph.D

CONTACT

86020666736662012 fangjnu@gmail.com

Data from ClinicalTrials.gov

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