Synergistic Effects of PARP Inhibition with Cisplatin and Hyperthermia in Cytoreductive Surgery and HIPEC for Ovarian, Fallopian Tube, and Extraovarian Cancer

The primary objective of the PROOV study is to evaluate the **synergistic effect** of PARP inhibition in combination with cisplatin and hyperthermia during interval cytoreductive surgery and HIPEC in patients with **ovarian cancer**. This study aims to determine the potential enhancement of therapeutic efficacy through this combination, which could lead to improved clinical outcomes for patients with ovarian cancer, fallopian tube cancer, and extraovarian cancer. The clinical relevance of this objective lies in its potential to offer a more effective treatment strategy for these malignancies, which are often challenging to treat with conventional therapies alone.

The clinical trial involves a study population consisting exclusively of **female** participants, as male subjects are not included. The age range of the participants falls within categories 3 and 4, which typically correspond to adult and middle-aged groups. The trial focuses on individuals diagnosed with **fallopian tube cancer**, **ovarian cancer**, or **extraovarian cancer**. The sponsor has not provided information regarding the total number of participants. The selection process for the trial population does not include vulnerable populations. No specific lifestyle considerations such as diet, physical activity, or habits have been highlighted. The sponsor has not disclosed key inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the synergistic effect of **PARP inhibition** with cisplatin and hyperthermia during interval cytoreductive surgery and HIPEC in patients with **ovarian cancer**, **fallopian tube cancer**, and **extraovarian cancer**. This study is structured as a Phase I/II trial, with a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The trial is expected to commence recruitment on April 15, 2025, and is projected to conclude by May 1, 2034, encompassing a comprehensive duration to assess both short-term and long-term outcomes.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful enrollment, participants will attend regular follow-up visits to monitor treatment effects, manage any adverse events, and ensure adherence to the study protocol. The end-of-study visit will mark the completion of the participant's involvement, where final assessments will be conducted to evaluate the primary and secondary endpoints of the trial.

The expected length of participant involvement will vary depending on individual response to treatment and the specific phase of the trial in which they are enrolled. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent, or any other medical or ethical considerations that necessitate discontinuation. The trial is meticulously designed to uphold the highest standards of scientific rigor and ethical responsibility, ensuring the safety and well-being of all participants throughout the study duration.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial will assess efficacy through a structured evaluation process. The trial is scheduled to commence recruitment on April 15, 2025, with an estimated completion date of May 1, 2034. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Specific parameters or endpoints for evaluating efficacy have not been detailed in the provided data. The trial will follow a systematic approach to measure, collect, and analyze efficacy data, although the exact methods and tools for these assessments are not specified. The trial's design and execution will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy outcomes.