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

NCT ID: NCT04913662

Last Updated: 2021-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stomach Neoplasm Peritoneal Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PIPAC Paclitaxel with FOLFOX

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

Group Type EXPERIMENTAL

Pressurized Intraperitoneal Aerosol Chemotherapy

Intervention Type PROCEDURE

Aerosolization of chemotherapic agent for intraperitoneal chemotherapy

Interventions

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Pressurized Intraperitoneal Aerosol Chemotherapy

Aerosolization of chemotherapic agent for intraperitoneal chemotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospicare Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyung-Ho Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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So Hyun Kang

Role: CONTACT

+82-10-7334-7124

Facility Contacts

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So Hyun Kang

Role: primary

+82-10-7334-7124

Other Identifiers

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SNUBH_PIPAC_PTX

Identifier Type: -

Identifier Source: org_study_id

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