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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291211
Recruitment Status : Unknown
Verified September 2014 by Tang-Du Hospital.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

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)

Condition or disease Intervention/treatment Phase
Stage IV Gastric Cancer Drug: S-1 plus cisplatin HIPEC Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: S-1 plus cisplatin HIPEC
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.
Drug: S-1 plus cisplatin HIPEC
Using cisplatin in HIPEC plus oral S-1
Other Name: hyperthermic intraperitoneal chemoperfusion




Primary Outcome Measures :
  1. PFS: Progression Free Survival [ Time Frame: 2 years ]
    from randomization to disease progression or death


Secondary Outcome Measures :
  1. OS: Overall Survival [ Time Frame: 5 years ]
    from randomization to death from any cause

  2. Safety as measured by recording the subjects' Adverse Events from randomization to termination [ Time Frame: 2 years ]
    Record the subjects' AEs from randomization to termination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291211


Contacts
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Contact: Helong Zhang, Professor 029-87777225 cnxazhl@163.com

Locations
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China, Shaanxi
IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 029
Contact: Lina Liu    029-84777631    tangduec@126.com   
Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Principal Investigator: Helong Zhang, Professor Tang-Du Hospital
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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02291211    
Other Study ID Numbers: TDCCC006
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Antineoplastic Agents