Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer

April 10, 2020 updated by: Bin Xiong, MD, Wuhan University

A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer

The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy combined with HIPEC is superior to only radical gastrectomy in terms of overall survival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive postoperative chemotherapy (6 circles together with neoadjuvant chemotherapy) and are followed up for 5 years or until death.

The trial is designed as a prospective, randomized, open and parallel group study.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

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
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Wuhan University
        • Contact:

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological proved diagnosis of locally advanced gastric cancer.
  • No evidence of distant metastases or peritoneal metastases.
  • Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage.
  • Eligible for radical gastrectomy with D2 lymphadenectomy.
  • Have not received cytotoxic chemotherapy or radiotherapy.
  • Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

  • Existence of distant metastasis or peritoneal metastasis during surgery (M1).
  • Any previous chemotherapy or radiotherapy
  • Active systemic infections
  • Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
  • Female patients who are pregnant or breast feeding

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
Sham Comparator: Without HIPEC
Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
Procedure: D2 radical gastrectomy
radical gastrectomy with D2 lymphadenectomy
Other Names:
  • Surgery
Drug: SOX neoadjuvant or postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
Other Names:
  • Chemotherapy
Experimental: With HIPEC
Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy)
Procedure: D2 radical gastrectomy
radical gastrectomy with D2 lymphadenectomy
Other Names:
  • Surgery
Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)
Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
Other Names:
  • HIPEC
Drug: SOX neoadjuvant or postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
Other Names:
  • Chemotherapy

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
Time Frame
progression-free survival
Time Frame: 5 years
5 years
distant metastasis rate
Time Frame: 5 years
5 years
peritoneal metastasis rate
Time Frame: 5 years
5 years
local recurrence rate
Time Frame: 5 years
5 years
complication rate
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Wuhan 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 (Actual)

April 1, 2020

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WuhanZN_HIPEC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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