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

Primary Purpose

Stage Ⅲ Gastric Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HIPEC
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage Ⅲ Gastric Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

D2 radical gastrectomy+Systemic chemotherapy

D2 radical gastrectomy+HIPEC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

DFS: Disease-Free Survival
from the date of random to the date of recurrence or death for disease progression.

Secondary Outcome Measures

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

Full Information

First Posted
November 11, 2014
Last Updated
March 17, 2015
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02396498
Brief Title
SP Intravenous Chemotherapy Versus SP by HIPEC in Stage Ⅲ Patients After D2 Gastrectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage Ⅲ Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D2 radical gastrectomy+Systemic chemotherapy
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
D2 radical gastrectomy+HIPEC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
HIPEC
Other Intervention Name(s)
hyperthermic intraperitoneal chemoperfusion
Intervention Description
Using cisplatin in HIPEC plus oral S-1
Primary Outcome Measure Information:
Title
DFS: Disease-Free Survival
Description
from the date of random to the date of recurrence or death for disease progression.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
OS: Overall Survival
Description
From the date of random to the date of death or to the end of follow-up
Time Frame
5 years
Title
The quality of life
Description
The subjects should finish the quality of life scale by themselves before treament in every cycle.
Time Frame
6 months
Title
Safety as measured by Adverse Events and Serious Adverse events In the process of the total treatment according CTCAE4.0
Description
record and collect subjects' AE and SAE In the process of the total treatment according CTCAE4.0
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helong Zhang, Professor
Phone
029-87777225
Email
cnxazhl@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helong Zhang, Professor
Organizational Affiliation
Tang-Du Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Liu
Phone
029-84777631
Email
tangduec@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35100917
Citation
Liu L, Sun L, Zhang N, Liao CG, Su H, Min J, Song Y, Yang X, Huang X, Chen D, Chen Y, Zhang HW, Zhang H. A novel method of bedside hyperthermic intraperitoneal chemotherapy as adjuvant therapy for stage-III gastric cancer. Int J Hyperthermia. 2022;39(1):239-245. doi: 10.1080/02656736.2022.2028018.
Results Reference
derived

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

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