Combined treatment of intraperitoneal chemotherapy after optimal interval surgery in advanced ovarian cancer

The primary objective of this clinical study is to investigate the feasibility, efficacy, and safety of combined administration of **HIPEC** with cisplatin (100 mg/m² body surface area) and postoperative bidirectional chemotherapy (intraperitoneal and systemic) following cytoreduction in patients with stage IIIB-C/IV **ovarian cancer** treated with neoadjuvant systemic chemotherapy. The safety of the combined treatment will be assessed by collecting complications and adverse effects, which will be compared to morbidity and mortality described in the scientific literature. Efficacy will be evaluated in terms of overall survival and disease-free survival at 1, 3, and 5 years. Overall survival is defined as the time from surgical intervention to patient death, while the disease-free interval is the time from surgery to disease recurrence. Recurrence criteria include an elevation of CA125 >70 U/mL if it was <35 U/mL after treatment, or an elevation to twice the lowest value obtained if CA125 did not normalize. Recurrence diagnosis must be confirmed by new lesions in imaging studies or pathological confirmation.

Secondary objectives include evaluating the Quality of Life parameters of patients before surgery, before the start of treatment, and after its completion at 3 and 6 months.

The clinical trial focuses on **ovarian cancer** and involves a study population exclusively comprising women aged between 18 and 70 years. Participants are required to have a confirmed histological diagnosis of FIGO stage IIIB-C/IV epithelial ovarian cancer, specifically high-grade serous epithelial carcinoma. The trial does not include a vulnerable population, and only female subjects are eligible. Participants must have undergone neoadjuvant chemotherapy with a total of three systemic cycles. The selection criteria emphasize adequate functional status, with a Karnofsky index greater than 70 or a performance status of 2 or less. Additionally, participants must demonstrate correct liver, renal, and bone marrow function, and be free from cardiac, pulmonary, hepatic, renal, or neurological diseases that would contraindicate major surgery. The sponsor has not provided information regarding the total number of participants in the study. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the feasibility, effectiveness, and safety of a combined treatment approach for patients with advanced **ovarian cancer**. This study involves the administration of hyperthermic intraperitoneal chemotherapy (HIPEC) with **cisplatin** at a dose of 100 mg/m², followed by postoperative bidirectional chemotherapy, which includes both intraperitoneal and systemic administration. The trial is structured as a non-commercial, low-intervention study, with the treatment regimens being part of routine clinical practice. The trial is randomized, double-blind, and controlled, ensuring the reliability and validity of the results.

The trial is expected to run from December 2022 to December 2027, with participants involved for a maximum treatment period of four months. The study includes several key visits: an initial screening visit to confirm eligibility, follow-up visits to monitor treatment response and adverse effects, and an end-of-study visit to assess overall outcomes. The primary endpoints focus on postoperative morbidity and mortality, while secondary endpoints include quality of life assessments using the EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires.

Participants are women aged 18-70 with a histological diagnosis of FIGO stage IIIB-C/IV epithelial ovarian cancer, who have undergone complete cytoreduction without digestive anastomosis and have received three cycles of neoadjuvant chemotherapy. Inclusion criteria also require adequate functional, liver, renal, and bone marrow function, as well as the absence of contraindicating diseases. Participants must provide informed consent and have a negative pregnancy test if of childbearing age. Conditions for early termination from the study include the development of contraindicating health issues or withdrawal of consent.

The clinical trial involves the administration of **Paclitaxel**, marketed as Paclitaxel Hospira 6 mg/ml concentrado para solución para perfusión EFG. This experimental medication is provided in the form of a **solution for infusion**. The active substance, paclitaxel, is of chemical origin and is administered via **intravenous infusion**. The dosing regimen for paclitaxel is set at a maximum daily dose of 175 mg/m², with a total maximum dose of 235 mg/m² over a treatment period of up to 4 cycles. The pharmaceutical product is manufactured by Hospira Invicta, S.A., and is not a pediatric formulation. Participant compliance with the dosing schedule will be monitored throughout the trial.

Another experimental medication used in the trial is **Cisplatin**, marketed as Cisplatino Pharmacia 1 mg/ml concentrado para solución para perfusión EFG. Similar to paclitaxel, cisplatin is also provided as a **solution for infusion** and is administered through **intravenous infusion**. The active substance, cisplatin, is of chemical origin. The dosing schedule for cisplatin involves a maximum daily dose of 100 mg/m², with a total maximum dose of 100 mg/m² over a treatment period of up to 4 cycles. This product is manufactured by Pharmacia Nostrum, S.A., and is also not a pediatric formulation. Compliance with the administration protocol will be closely monitored to ensure adherence to the study's requirements.

In this clinical trial, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus is on evaluating the feasibility, efficacy, and safety of the combined administration of these chemotherapeutic agents in patients with advanced ovarian cancer. The trial aims to assess overall survival and disease-free survival, with compliance and adverse effects being systematically recorded and analyzed.

Efficacy in this clinical trial will be assessed by evaluating **overall survival** and **disease-free survival** at 1, 3, and 5 years. Overall survival is defined as the time interval from the surgical intervention to the death of the patient. Disease-free survival is defined as the time from surgery to the occurrence of disease recurrence. Recurrence criteria include an elevation of CA125 levels to greater than 70 U/mL if post-treatment levels were below 35 U/mL, or an increase to twice the lowest value obtained with treatment if CA125 did not normalize. A definitive diagnosis of recurrence must be confirmed by the appearance of new lesions in imaging studies or pathological confirmation.