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S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
Conditions
Stage IV Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1 plus cisplatin HIPEC
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
Xi'an, Shaanxi, China
Status: Recruiting
Contact: Lina Liu - 029-84777631 - tangduec@126.com
Start Date
September 2014
Completion Date
December 2016
Sponsors
Tang-Du Hospital
Source
Tang-Du Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page