IMproving the outcome of Peritoneal and Pleural metastases using Aerosolized ChemoTherapy

Improved therapy of peritoneal metastases (PM) and malignant pleural effusion (MPE) is an important clinical need. Recently, intracavitary aerosolized drug delivery (ADD) has been introduced in the treatment of PM and MPE. This innovative, EU developed therapy involves nebulization of chemotherapy during either laparoscopy (pressurized intraperitoneal aerosolized chemotherapy, PIPAC) or thoracoscopy (pressurized intraperitoneal aerosolized chemotherapy, PIPAC). Also, preliminary data suggest that ADD may be optimized by using electrostatic precipitation (ESP). As yet, however, no randomized trials have tested the efficacy of PIPAC or PITAC. The IMPACT project aims to establish ADD as a novel standard of care in patients with PM and MPE. First, a comprehensive assessment of patient needs and expectations will be performed, supported by experts in participatory research methods. Based on the input of multiple stakeholders including patients, methodologists, and health care professionals, three randomized clinical trials will be designed in PM from colorectal and gastric cancer, and in MPE. These trials will be run in more than 30 clinical sites in 7 EU countries, and will include >500 patients. In a subgroup of patients, the effects of ESP on drug distribution and tumor tissue penetration will be studied. In addition to clinical and patient related outcomes, health technological assessment will be performed to establish cost effectiveness and value in diverse EU health care systems. To reach all relevant stakeholders, a broad range of communication, exploitation, and dissemination tasks will be performed in order to maximize the visibility and impact of the project results. In parallel, a modular implementation strategy will be deployed to maximize clinical adoption of this innovative treatment strategy and ensure acceptability, usability, and scalability in diverse health care settings.This action is part of the Cancer Mission cluster of projects on “Diagnosis and Treatment-Innovative Surgery