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

September 12, 2014 updated by: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

582

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510095
        • Recruiting
        • Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • shuzhong cui, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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