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S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis

Primary Purpose

Stage IV Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

S-1 plus cisplatin HIPEC

About this trial

This is an interventional treatment trial for Stage IV Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria:

18 ≤ age ≤ 70 years old
Patients with histologically confirmed gastric cancer (adenocarcinoma), stage IV (limited to the abdominal cavity), accpeted palliative cytoreductive surgery and no prior chemotherapy, biological therapy or targeted anti-cancer 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:

Known to have abdominal viscera metastasis of gastric cancer patients
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
Have the history of allograft transplantation
Conducted the autologous bone marrow transplantation in 4 weeks
Participate in other clinical trial before the start of this trial in 4 weeks
Patient compliance is bad or researchers believe that patients are not suitable for this treatment
Known to have active hepatitis patients
HER-2-positive patients (ICH3+or FISH+)
History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1 plus cisplatin HIPEC

Arm Description

8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after palliative operation gastric cancer of stage IV limited peritoneal metastasis. 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

PFS: Progression Free Survival

from randomization to disease progression or death

Secondary Outcome Measures

OS: Overall Survival

from randomization to death from any cause

Safety as measured by recording the subjects' Adverse Events from randomization to termination

Record the subjects' AEs from randomization to termination

Full Information

NCT ID

NCT02291211

First Posted

November 11, 2014

Last Updated

November 13, 2014

Sponsor

Tang-Du Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02291211

Brief Title

S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis

Official Title

Phase Ⅱ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

October 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

This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery (CRS)

Detailed Description

This project is a single-center, open clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept S-1 plus hyperthermic intraperitoneal chemotherapy . With advanced gastric patients of confined to the peritoneal after CRS as the research object, with progression-free survival and overall survival, adverse events as the end points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage IV Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

S-1 plus cisplatin HIPEC

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

S-1 plus cisplatin HIPEC

Other Intervention Name(s)

hyperthermic intraperitoneal chemoperfusion

Intervention Description

Using cisplatin in HIPEC plus oral S-1

Primary Outcome Measure Information:

Title

PFS: Progression Free Survival

Description

from randomization to disease progression or death

Time Frame

2 years

Secondary Outcome Measure Information:

Title

OS: Overall Survival

Description

from randomization to death from any cause

Time Frame

5 years

Title

Safety as measured by recording the subjects' Adverse Events from randomization to termination

Description

Record the subjects' AEs from randomization to termination

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 ≤ age ≤ 70 years old Patients with histologically confirmed gastric cancer (adenocarcinoma), stage IV (limited to the abdominal cavity), accpeted palliative cytoreductive surgery and no prior chemotherapy, biological therapy or targeted anti-cancer 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: Known to have abdominal viscera metastasis of gastric cancer patients 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 Have the history of allograft transplantation Conducted the autologous bone marrow transplantation in 4 weeks Participate in other clinical trial before the start of this trial in 4 weeks Patient compliance is bad or researchers believe that patients are not suitable for this treatment Known to have active hepatitis patients HER-2-positive patients (ICH3+or FISH+) History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Helong Zhang, Professor

Phone

029-87777225

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

tangduec@126.com

12. IPD Sharing Statement

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S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis

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