Phase II Multicenter Randomized Trial of PIPAC and Systemic Chemotherapy Versus Systemic Chemotherapy Alone in First-Line Treatment of Malignant Peritoneal Mesothelioma

The primary objective of this Phase II multicenter randomized trial is to evaluate the association of **Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)** and systemic chemotherapy versus systemic chemotherapy alone as a first-line treatment for **Malignant Peritoneal Mesothelioma**. This study aims to determine whether the addition of PIPAC to systemic chemotherapy improves clinical outcomes in patients with this condition, which is characterized by a poor prognosis and limited treatment options. The clinical relevance of this objective lies in potentially enhancing therapeutic efficacy and improving survival rates for patients with Malignant Peritoneal Mesothelioma.

The clinical trial involves participants diagnosed with **Malignant Peritoneal Mesothelioma**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or the selection process for the trial population. There are no specific lifestyle considerations such as diet, physical activity, or habits mentioned. Additionally, key inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is a **Phase II** multicenter, randomized study designed to evaluate the efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in combination with systemic chemotherapy compared to systemic chemotherapy alone as a first-line treatment for **Malignant Peritoneal Mesothelioma**. The trial employs a **randomized, controlled** design to ensure the reliability of the results. The study is expected to span from July 1, 2020, to July 1, 2026, providing a comprehensive evaluation period for the treatment's effectiveness.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following randomization, participants will attend regular follow-up visits to monitor treatment response and any adverse effects. These visits are crucial for collecting data on the primary and secondary endpoints of the trial. The end-of-study visit will conclude the participant's involvement, allowing for a final assessment of the treatment's impact.

The expected duration of participant involvement will vary depending on individual response to treatment and overall health status. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial's design ensures that all procedures are conducted in accordance with ethical standards and regulatory requirements, maintaining the integrity of the research and the safety of the participants.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on the administration of other medicinal products or their role in the trial.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is not included in the available data. The documentation lacks specifics on the **product's authorization status**, pharmaceutical form, and the origin of the active substances.

The clinical trial is designed to assess efficacy within the context of a Phase 4 study. The trial is scheduled to commence recruitment on July 1, 2020, with an estimated completion date of July 1, 2026. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will adhere to rigorous standards typical of Phase 4 studies, ensuring that the efficacy outcomes are reliable and valid. The analysis will be conducted in accordance with the trial's protocol, utilizing appropriate statistical methods to evaluate the collected data. The trial's design and execution will follow established clinical guidelines to ensure the integrity and scientific validity of the efficacy assessments.