SP Intravenous Chemotherapy Versus SP by HIPEC in Stage Ⅲ Patients After D2 Gastrectomy

March 17, 2015 updated by: Tang-Du Hospital

S-1 With Cisplatin Intravenous Chemotherapy Versus S-1 Plus Cisplatin Hyperthermic Intraperitoneal Chemotherapy in Stage Ⅲ Patients After D2 Gastrectomy：a Randomized Controlled Study

The study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study is a randomized clinical trial，and subjects wuill be assigned two arms: SP Intravenous Chemotherapy or SP by HIPEC .After 8 cycles treatment,we assess the safety and efficacy.

Study Type

Interventional

Enrollment (Anticipated)

270

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
    • Shaanxi
      • Xi'an, Shaanxi, China, 029
        • Recruiting
        • IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 ≤ age ≤ 70 years old
  • Histologically diagnosed as stageⅢ gastric adenocarcinoma，and perform D2 radical gastrectomy，as well as have not received any Anti-tumor therapy：chemotherapy,biological treatment or molecular targeted therapy , etc.
  • The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
  • Having given written informed consent prior to any procedure related to the study
  • Expected survival time ≥3 months

Exclusion Criteria:

  • History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin
  • Hemoglobin<90g/L

  • Inadequate hematopoietic function which is defined as below:

    • white blood cell (WBC) less than 3,500/mm^3
    • absolute neutrophil count (ANC) less than 1,500/mm^3
    • platelets less than 80,000/mm^3

  • Inadequate hepatic or renal function which is defined as below:

    • serum bilirubin greater than 2 times the upper limit of normal range
    • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
    • blood creatinine level greater than 1.5 times ULN,Creatinine clearance<60ml/min
  • Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
  • Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
  • Psychiatric disorder or symptom that makes participation of the patient difficult
  • Myocardial infarction, existing serious or unstable angina, and patients with cardiac insufficiency in 6 months
  • Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
  • Known DPD deficiency
  • Participate in other clinical trial before the start of this trial
  • Patient compliance is bad or researchers believe that patients are not suitable for this treatment
  • Known to have active hepatitis patients

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
Placebo Comparator: D2 radical gastrectomy+Systemic chemotherapy
8 cycles of systemic chemotherapy were performed for stage Ⅲ patients after D2 gastrectomy .Systemic chemotherapy(SP): Cisplatin: 60mg/m^2, d1 , Intravenous infusion, every 3 weeks. S-1: 40-60mg/m^2 bid, days 1-14, every 3 weeks .Subjects should be given maximum 8 cycles, or progression/intolerance.
Experimental: D2 radical gastrectomy+HIPEC
8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after D2 radical gastrectomy. HIPEC was conducted in d1 and d3: Normal saline 2000ml-5000ml, Cisplatin 60mg/m^2, 43°C, 60min. every 3 weeks. S-1: 40-60mg/m^2 bid, days 1-14, every 3 weeks.Subjects should be given maximum 8 cycles, or progression/intolerance.
Drug: HIPEC
Using cisplatin in HIPEC plus oral S-1
Other Names:
  • hyperthermic intraperitoneal chemoperfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS: Disease-Free Survival
Time Frame: 2 years
from the date of random to the date of recurrence or death for disease progression.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS: Overall Survival
Time Frame: 5 years
From the date of random to the date of death or to the end of follow-up
5 years
The quality of life
Time Frame: 6 months
The subjects should finish the quality of life scale by themselves before treament in every cycle.
6 months
Safety as measured by Adverse Events and Serious Adverse events In the process of the total treatment according CTCAE4.0
Time Frame: 6 months
record and collect subjects' AE and SAE In the process of the total treatment according CTCAE4.0
6 months

Collaborators and Investigators

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

Sponsor

Tang-Du Hospital

Investigators

  • Principal Investigator: Helong Zhang, Professor, Tang-Du 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

April 1, 2014

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDCCC005

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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