Status:
UNKNOWN
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Hospicare Co., Ltd.
Conditions:
Stomach Neoplasm
Peritoneal Metastases
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with ...
Eligibility Criteria
Inclusion
- Pathologically diagnosed as gastric adenocarcinoma
- Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis
- HER-2 negative tumor
- 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
Exclusion
- 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
- History of gastrointestinal surgery
- Patients refusing treatment
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04913662
Start Date
April 26 2021
End Date
June 30 2022
Last Update
June 4 2021
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620