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NCT04913662 Clinical Trial

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis

Stomach Neoplasm Clinical Trial

Official title:
Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04913662
Other study ID # SNUBH_PIPAC_PTX
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 26, 2021
Est. completion date June 30, 2022

Study information
Verified date June 2021
Source Seoul National University Bundang Hospital
Contact So Hyun Kang
Phone +82-10-7334-7124
Email shkang@snubh.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 18
Est. completion date June 30, 2022
Est. primary completion date April 26, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 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 - History of gastrointestinal surgery - Patients refusing treatment

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Pressurized Intraperitoneal Aerosol Chemotherapy
Aerosolization of chemotherapic agent for intraperitoneal chemotherapy

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital Hospicare Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
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