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

Primary Purpose

Stomach Neoplasm, Peritoneal Metastases

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pressurized Intraperitoneal Aerosol Chemotherapy
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PIPAC Paclitaxel with FOLFOX

Arm Description

PIPAC (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)

Outcomes

Primary Outcome Measures

Recommended dose
Recommended dose of paclitaxel for a phase II trial

Secondary Outcome Measures

Full Information

First Posted
April 26, 2021
Last Updated
June 1, 2021
Sponsor
Seoul National University Bundang Hospital
Collaborators
Hospicare Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04913662
Brief Title
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
Official Title
Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
April 26, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Hospicare Co., Ltd.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm, Peritoneal Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PIPAC Paclitaxel with FOLFOX
Arm Type
Experimental
Arm Description
PIPAC (Paclitaxel) + Systemic mFOLFOX6(5-FU, Oxaliplatin, Leucovorin)
Intervention Type
Procedure
Intervention Name(s)
Pressurized Intraperitoneal Aerosol Chemotherapy
Intervention Description
Aerosolization of chemotherapic agent for intraperitoneal chemotherapy
Primary Outcome Measure Information:
Title
Recommended dose
Description
Recommended dose of paclitaxel for a phase II trial
Time Frame
Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
So Hyun Kang
Phone
+82-10-7334-7124
Email
shkang@snubh.org
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So Hyun Kang
Phone
+82-10-7334-7124
Email
shkang@snubh.org

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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