Intensive Intraperitoneal Chemotherapy in Patients with Advanced Ovarian Cancer

The primary objective of the study titled "Intensive Intraperitoneal Therapy in Advanced **Ovarian Cancer**" is not explicitly stated. However, the focus on intensive intraperitoneal therapy suggests an evaluation of its efficacy and safety in treating advanced stages of ovarian cancer. This is clinically relevant as ovarian cancer is a significant cause of morbidity and mortality, and optimizing treatment strategies could improve patient outcomes. There are no secondary objectives provided in the available data.

The clinical trial focuses on **ovarian cancer** and involves a study population exclusively composed of female participants. The age range of the participants falls within the categories of 18 to 64 years. The trial does not include vulnerable populations. The sponsor has not provided information regarding the total number of participants or specific selection criteria. There is no data available on the general health status, lifestyle considerations, or any key inclusion or exclusion criteria for the trial population. The sponsor has not disclosed further details about the trial's participant selection process.

The clinical trial is designed to evaluate the efficacy of **intensive intraperitoneal therapy** in patients with advanced **ovarian cancer**. This study is a Phase 4 trial, which typically involves post-marketing surveillance to gather additional information about the treatment's risks, benefits, and optimal use. The trial is structured as a randomized, double-blind, controlled study to ensure the reliability and validity of the results. The estimated recruitment start date was December 1, 2019, and the trial is expected to conclude by April 30, 2031, providing a comprehensive duration for data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough medical evaluation to confirm the diagnosis of ovarian cancer and ensure the absence of any exclusion criteria. Following successful screening, participants will be randomly assigned to either the treatment or control group, with neither the participants nor the investigators aware of the group assignments, maintaining the double-blind nature of the trial.

Throughout the study, participants will attend regular follow-up visits to monitor their response to the treatment and to identify any adverse effects. These visits will include clinical assessments, laboratory tests, and imaging studies as necessary. The frequency and specific procedures of these follow-up visits will be determined by the study protocol, ensuring consistent data collection across all participants. The end-of-study visit will mark the conclusion of the participant's involvement, during which final evaluations will be conducted to assess the overall outcomes of the treatment.

The expected length of participant involvement will vary depending on individual response and the study's specific requirements, but it will generally span several months to years. Conditions that may lead to early termination from the study include the occurrence of significant adverse events, withdrawal of consent by the participant, or any other medical or ethical reasons deemed necessary by the investigators. The trial's design and procedures are meticulously planned to ensure the safety and well-being of participants while providing valuable insights into the treatment of advanced ovarian cancer.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial is categorized as a Phase 4 study, which typically involves post-marketing surveillance to assess the efficacy and safety of a treatment in a larger population. The trial is scheduled to commence recruitment on December 1, 2019, and is estimated to conclude by April 30, 2031. The efficacy of the treatment will be evaluated through predefined primary and secondary endpoints, although specific details regarding these endpoints are not provided. The trial will likely employ standard methods for measuring and analyzing efficacy parameters, consistent with Phase 4 study protocols. The trial's design and execution will adhere to rigorous scientific and ethical standards to ensure the reliability and validity of the efficacy assessments.