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

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04913662
• Collaborator: Hospicare Co., Ltd. (Industry)
• Enrollment: 18
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.1
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasm; Peritoneal Metastases	Procedure: Pressurized Intraperitoneal Aerosol Chemotherapy	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
• Actual Study Start Date: Apr 26, 2021
• Anticipated Primary Completion Date: Apr 26, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Recommended dose [Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)]

   Recommended dose of paclitaxel for a phase II trial

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do	Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Bundang Hospital
• Hospicare Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyung-Ho Kim, Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT04913662
• Other Study ID Numbers: SNUBH_PIPAC_PTX
• First Posted: Jun 4, 2021
• Last Update Posted: Jun 4, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Neoplasm Metastasis; Stomach Neoplasms

Study Results

No Results Posted as of Jun 4, 2021