A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2 Lymphadenectomy

Affiliated Cancer Hospital & Institute of Guangzhou Medical University1 site in 1 country582 target enrollmentJuly 2014

ConditionsAdvanced Gastric Adenocarcinoma

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Advanced Gastric Adenocarcinoma
Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Enrollment: 582
Locations: 1
Primary Endpoint: Overall survival
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

July 2019

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Responsible Party

Sponsor

Eligibility Criteria

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)

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