Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer
NCT ID: NCT03237507
Last Updated: 2017-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
110 participants
OBSERVATIONAL
2017-07-01
2020-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chemotherapy Group
chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress
S-1
40-60mg/m\^2 bid, days 1-14, oral，every 3 weeks.
oxaliplatin
100mg/m\^2 days 1，intravenous infusion, every 3 weeks.
Chemotherapy plus HIPEC Group
Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
S-1
40-60mg/m\^2 bid, days 1-14, oral，every 3 weeks.
oxaliplatin
100mg/m\^2 days 1，intravenous infusion, every 3 weeks.
Hyperthermic Intraperitoneal
hyperthermic intraperitoneal chemoperfusion
Paclitaxel
intraperitoneal perfusion
Interventions
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S-1
40-60mg/m\^2 bid, days 1-14, oral，every 3 weeks.
oxaliplatin
100mg/m\^2 days 1，intravenous infusion, every 3 weeks.
Hyperthermic Intraperitoneal
hyperthermic intraperitoneal chemoperfusion
Paclitaxel
intraperitoneal perfusion
Eligibility Criteria
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Inclusion Criteria
* Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis
* Didn't received any prior systemic chemotherapy
* Signed informed consent
Exclusion Criteria
* Pregnancy or lactation women,
* Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3
* Inadequate organ function which is defined as below:
Total bilirubin \>2 pper limit of normal range (ULN); ALT / AST \> 2.5 upper limit of normal range (ULN); serum creatinine \> 1.5 mg/dL, and Ccr \> 60 ml/min (estimated by Cockcroft-Gault formulation);
* Symptomatic peripheral neuropathy
* Receiving a concomitant treatment with other fluoropyrimidines
* Fluoropyrimidines (DPD) congenital absence
* Other Situations which physicians suggesting are inadaptable for enrollment
18 Years
ALL
No
Sponsors
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Harbin Medical University
OTHER
Responsible Party
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Wang Kuan, M.D.Prof
Professor
Principal Investigators
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Kuan Wang
Role: PRINCIPAL_INVESTIGATOR
Harbin Medical University Cancer Hospital,Gastrointestinal Surgical department
Locations
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Countries
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Other Identifiers
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TOTPMSG1602
Identifier Type: -
Identifier Source: org_study_id
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