HIPEC, Intravenous Chemotherapy and Surgery for the Treatment of Advanced GC With Peritoneal Metastasis

September 14, 2015 updated by: Zhejiang Cancer Hospital

Hyperthermic Intraperitoneal Chemotherapy, Intravenous Chemotherapy Combined With Surgery for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis

Explore the hyperthermic intraperitoneal chemotherapy (HIPEC) and intravenous chemotherapy for Creating the Operation Chance in advanced gastric cancer with peritoneal metastasis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To assess the effectiveness and safety of Hyperthermic intraperitoneal chemotherapy, intravenous chemotherapy combined with surgery for the treatment of advanced gastric cancer with peritoneal metastasis,so as to further find out the optimal protocol for the Conversion therapy in the patients with advanced gastric cancer.

Study Type

Interventional

Enrollment (Anticipated)

40

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
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yian Du, MD
        • Sub-Investigator:
          • Pengfei Yu, 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:

gastric cancer confirmed by endoscopic biopsy , and enhanced CT suspected to have peritoneal metastasis, including ascites, ovarian metastasis, omentum or peritoneal metastasis.

  • Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary
  • Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
  • ECOG (Eastern Cooperative Oncology Group) : 0~2
  • Age: 18~75 years old
  • Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC>4.0×109/L, NEU >1.5×109/L, PLT>100×109/L, BIL<1.5 times of upper limit of normal reference value, ALT and AST<2.5 times of upper limit of normal reference value, and CRE<1.2mg/dl
  • Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases
  • Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver)
  • Not participating in other study projects before and during the treatment
  • Signed the Informed Consent Form

Exclusion Criteria:

  • Not conforming to above inclusion criteria
  • Distal metastasis to lung, liver, or para aortic lymph node metastasis
  • Ever operation on the stomach
  • Operation intolerance due to other systemic basic diseases
  • Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment
  • Allergy to the drugs in this protocol
  • Pregnant or lactating women
  • Women at childbearing age and of pregnancy desire during the study

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIPEC,Chemotherapy AND surgery
  1. surgical exploration,if PCI<20,then we perform this study
  2. HIPEC（RHL-2000B, Madain Medical Devices Co., Ltd., Jilin, China): Taxol (Paclitaxel Injection) 75 mg/m2, twice, within 72 hours after surgical exploration ; oral chemotherapy:S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules): 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
  3. chemotherapy(3 cycles) : Taxol 150mg/m2,d1, S-1: 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
  4. surgery:Secondary surgical exploration:if PCI less than 20,then perform the cytoreductive surgery(resection of primary tumors and metastases )
  5. after the surgery,HIPEC for two cycles,and PS chemotherapy for 3 cycles
Other: HIPEC,Chemotherapy AND surgery
  1. HIPEC（RHL-2000B, Madain Medical Devices Co., Ltd., Jilin, China): Taxol (Paclitaxel Injection) 75 mg/m2, twice, within 72 hours after surgical exploration ; oral chemotherapy:S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules): 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
  2. chemotherapy(PS for 3 cycles) : Taxol 150mg/m2,d1, S-1: 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
  3. surgery:Secondary surgical exploration:if PCI less than 20,then perform the cytoreductive surgery(resection of primary tumors and metastases )
  4. after the surgery,HIPEC for two cycles,and PS chemotherapy for 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection
Time Frame: 3 months
the rate of R0 resection
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 6 months
Number and degree of Adverse Events
6 months
Overall survival time
Time Frame: 3 years
the overall survival time
3 years

Collaborators and Investigators

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

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Yian Du, MD, Zhejiang Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 7, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HISA

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.

Clinical Trials on Gastric Cancer

Clinical Trials on HIPEC,Chemotherapy AND surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe