Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0007061
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria:
- Pathologically diagnosed as gastric adenocarcinoma
- Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis
- Patients set to undergo FOLFOX as systemic chemotherapy regimen after a multidisciplinary meeting
- Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)
- Absolute Neutrophil Count: ? 1,500/mm³
- Hemoglobin level: ? 8.0g/dL
- Platelet Count: ? 10×104/mm³
- AST (GOT), ALT (GPT): ? 100U/L
- Total Bilirubin: ? 2.0mg/dL
- Creatinine Clearance (CCl): ? 50mL/min
- ECOG 0 - 2
- HER-2 negative tumor
- age of or over 20 and less than 80 years
- agreed to the informed consent
Exclusion Criteria:
- Patients with other major medical disease or malignant tumors other than gastric cancer
- Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
- Pregnant, breast-feeding women or with birth plan
- Patients refusing treatment
- Patients who are totally dependent on parenteral nutrition
- Having allergies to anticancer agents
- Who have anticipated lifespan of less than 3 months
- Small bowel ileus
- Distant metastasis in other organs (except lymph nodes and Krukenberg/ovaries)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recommended phase II dose for PIPAC Paclitaxel
- Secondary Outcome Measures
Name Time Method Survival (1-year overall survival and progression-free survival), tumor response, peritoneal metastasis response, conversion surgery rate