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

Advanced Gastric Adenocarcinoma Clinical Trial

— HIPEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02240524
• Other study ID #: 2014514
• Status: Recruiting
• Phase: Phase 3
• First received: June 3, 2014
• Last updated: September 12, 2014
• Start date: July 2014
• Est. completion date: July 2019

Study information

• Verified date: September 2014
• Source: Affiliated Tumor Hospital of Guangzhou Medical University
• Contact: zhiyuan fang, Ph.D
• Phone: 86020666736662012
• Email: fangjnu[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 582
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Advanced Gastric Adenocarcinoma

Intervention

Procedure:
• D2 lymphadenectomy
The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.
• Systemic chemotherapy

• HIPEC

Locations

Country	Name	City	State
China	Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Tumor Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	From the date of surgery to the date of death or to the end of follow-up	5 years	No
Secondary	Recurrence-free survival	From the date of surgery to the date of recurrence or to the end of follow-up	5 years	No
Secondary	Locoregional-free survival	From the date of surgery to the date of locoregional recurrence or to the end of follow-up	5 years	No
Secondary	Hepatic metastases-free survival	From the date of surgery to the date of recurrence or to the end of follow-up	5 years	No