Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients

March 4, 2015 updated by: Wenxian Guan, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Prospective Phase III Trial Using Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients Including Adenocarcinoma of the Esophagogastric Junction

Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The objective of the trial is to compare the treatment of patients with advanced gastric cancer without evidence of distant metastases treated with D2 radical gastrectomy and intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients treated with D2 radical gastrectomy alone and postoperative chemotherapy (Group A).

The hypothesis of the trial is that D2 radical gastrectomy with intraperitoneal chemoperfusion (Group B) is superior to D2 radical gastrectomy (Group A) in terms of overall survival.

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

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Contact Backup

  • Name: Wenxian Guan
  • Phone Number: 86-83106666-60931
  • Email: guan_wx@163.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Meng Wang
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wenxian Guan, MD
        • Sub-Investigator:
          • Baorui Liu, MD
        • Sub-Investigator:
          • Meng Wang, MD

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 peritoneal metastasized gastric cancer including carcinoma of the AEG.
  • No evidence of distant metastases
  • preoperative examination (CT/MRI) demonstrated resectable gastricc cancer with T3-T4 stage
  • Written informed consent is obtained prior to commencement of trial treatment

Exclusion Criteria:

  • Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer
  • Active systemic infections
  • Patients with known interstitial lung disease with New York Heart Association classification > 2
  • Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure
  • cardiac arrhythmia
  • Inadequate renal function at the beginning of the trial, defined as GFR less than <60 ml/min
  • Inadequate liver function at the beginning of the trial, defined as Bilirubin >1.5 times ULN
  • Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than <150 GPT/L or neutrophil granulocyte count less than <1.5 GPT/
  • Active vaccination within 6 weeks prior to randomisation
  • Active hepatitis B or C infection
  • Female patients who are pregnant or breast feeding
  • Missing of capacity to contract
  • contraindication to the drugs which are used in the trial
  • Participation in another therapeutic clinical trial

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: without HIPEC
Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and postoperative chemotherapy (SOX or XELOX).
Experimental: with HIPEC

Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and intraperitoneal chemoperfusion with cisplatin and postoperative chemotherapy as described for the control group.

Cisplatin: 75mg/m2 (max 150mg/m2 max 5L )
Procedure: intraperitoneal chemoperfusion
HIPEC with cisplatin at the time of D2 radical surgery
Other Names:
  • HIPEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 24 months
overall survival [ Time Frame: Death or 2 years ]
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complication rate
Time Frame: 30 days
30 days
time to progress
Time Frame: 24 months
follow up every 3 months till 24 months end of study
24 months
time to distant metastasis
Time Frame: 24 months
time to other distant metastases follow up every 3 months till 24 months
24 months

Collaborators and Investigators

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Wenxian Guan, China Health Ministry

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

January 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

February 28, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NDTHNanjingUMS

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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