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

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

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 Overview

• Status: Unknown
• Conditions: Advanced Gastric Adenocarcinoma
• Intervention / Treatment: Procedure: Systemic chemotherapy; Procedure: HIPEC; Procedure: D2 lymphadenectomy

• Study Type: Interventional
• Enrollment (Anticipated): 582
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510095
      • Recruiting
      • Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
      • Contact: zhiyuan fang, Ph.D; Phone Number: 86020666736662012; Email: fangjnu@gmail.com
      • Principal Investigator: shuzhong cui, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D2 lymphadenectomy and HIPEC and Systemic chemotherapy; Intraoperative and postoperative hyperthermic intraperitoneal chemotherapy (twice HIPEC) were performed after radical gastrectomy with D2 lymphadenectomy, followed by 8 cycles of systemic chemotherapy. HIPEC was conducted within 48 h after surgery: Normal saline 3000ml-4000ml, Paclitaxel 75mg/m^2, 43°C, 60min. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.	Procedure: Systemic chemotherapy; Procedure: HIPEC; Other Names: hyperthermic intraperitoneal chemoperfusion; Procedure: D2 lymphadenectomy; The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.
Placebo Comparator: D2 lymphadenectomy+Systemic chemotherapy; 8 cycles of systemic chemotherapy were performed after radical gastrectomy with D2 lymphadenectomy. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.	Procedure: Systemic chemotherapy; Procedure: D2 lymphadenectomy; The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	From the date of surgery to the date of death or to the end of follow-up	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival	From the date of surgery to the date of recurrence or to the end of follow-up	5 years
Locoregional-free survival	From the date of surgery to the date of locoregional recurrence or to the end of follow-up	5 years
Hepatic metastases-free survival	From the date of surgery to the date of recurrence or to the end of follow-up	5 years

Collaborators and Investigators

• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Investigators: Study Director: shuzhong cui, Ph.D, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: September 12, 2014
• First Posted (Estimate): September 15, 2014

Study Record Updates

• Last Update Posted (Estimate): September 15, 2014
• Last Update Submitted That Met QC Criteria: September 12, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Capecitabine; HIPEC; Paclitaxel; Gastric adenocarcinoma; Oxaliplatin
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 2014514