Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer
- Conditions
- Stage IV Gastric Cancer With Metastasis
- Interventions
- Registration Number
- NCT03237507
- Lead Sponsor
- Harbin Medical University
- Brief Summary
This is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
- 18 ≤ age
- 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
- History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chemotherapy Group oxaliplatin chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress Chemotherapy Group S-1 chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress Chemotherapy plus HIPEC Group S-1 Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy Chemotherapy plus HIPEC Group oxaliplatin Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy Chemotherapy plus HIPEC Group Hyperthermic Intraperitoneal Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy Chemotherapy plus HIPEC Group Paclitaxel Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
- Primary Outcome Measures
Name Time Method PFS: Progression Free Survival through study completion, an average of 1 year time from enrollment to disease progression or death
- Secondary Outcome Measures
Name Time Method OS:overall survival 3 years time from enrollment to death
Safety 3 years measured by recording the subjects' Adverse Events according to CTCAE 4.03
Trial Locations
- Locations (1)
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China