Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
1 other identifier
interventional
18
1 country
1
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 peritoneal metastasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2021
CompletedStudy Start
First participant enrolled
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedJune 4, 2021
June 1, 2021
1 year
April 26, 2021
June 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Recommended dose
Recommended dose of paclitaxel for a phase II trial
Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)
Study Arms (1)
PIPAC Paclitaxel with FOLFOX
EXPERIMENTALPIPAC (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
Interventions
Aerosolization of chemotherapic agent for intraperitoneal chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Bundang Hospitallead
- Hospicare Co., Ltd.collaborator
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 26, 2021
First Posted
June 4, 2021
Study Start
April 26, 2021
Primary Completion
April 26, 2022
Study Completion
June 30, 2022
Last Updated
June 4, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR