Safety and Efficacy of Cisplatin and Doxorubicin Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients with Ovarian Cancer with Peritoneal Metastases: A Multicenter US Phase I Trial.

ABSTRACT:

Background

Pressurized intraperitoneal aerosolized chemotherapy (PIPAC) is a novel, minimally invasive method of delivering intraperitoneal chemotherapy with promising peritoneal disease control in ovarian cancer.

Methods

This US multicenter prospective phase I trial (NCT04329494) evaluated the safety and efficacy of PIPAC cisplatin 10.5 mg/m² and doxorubicin 2.1 mg/m² (PIPAC-CD) every 6 weeks in ovarian cancer at three US centers. Primary endpoints were dose-limiting toxicities and adverse events. Secondary endpoints included response according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, laparoscopic peritoneal carcinomatosis index, histologic peritoneal regression grading score, progression-free survival (PFS), and overall survi

SUBMITTER: Nakamura B 

PROVIDER: S-EPMC12689763 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature