Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer
Overview
- Phase
- N/A
- Intervention
- S-1
- Conditions
- Stage IV Gastric Cancer With Metastasis
- Sponsor
- Harbin Medical University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- PFS: Progression Free Survival
- Last Updated
- 8 years ago
Overview
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
Investigators
Wang Kuan, M.D.Prof
Professor
Harbin Medical University
Eligibility Criteria
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
- •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
Arms & Interventions
Chemotherapy Group
chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress
Intervention: S-1
Chemotherapy Group
chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress
Intervention: oxaliplatin
Chemotherapy plus HIPEC Group
Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
Intervention: S-1
Chemotherapy plus HIPEC Group
Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
Intervention: oxaliplatin
Chemotherapy plus HIPEC Group
Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
Intervention: Hyperthermic Intraperitoneal
Chemotherapy plus HIPEC Group
Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
Intervention: Paclitaxel
Outcomes
Primary Outcomes
PFS: Progression Free Survival
Time Frame: through study completion, an average of 1 year
time from enrollment to disease progression or death
Secondary Outcomes
- OS:overall survival(3 years)
- Safety(3 years)