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

June 1, 2021 updated by: Hyung-Ho Kim, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PIPAC Paclitaxel with FOLFOX
PIPAC (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
Procedure: Pressurized Intraperitoneal Aerosol Chemotherapy
Aerosolization of chemotherapic agent for intraperitoneal chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended dose
Time Frame: Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)
Recommended dose of paclitaxel for a phase II trial
Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Hospicare Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 26, 2021

Primary Completion (ANTICIPATED)

April 26, 2022

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (ACTUAL)

June 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_PIPAC_PTX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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