Ovarian cancer (OV-1) MedDRA version: 21.1 Level: PT Classification code 10070907 Term: Ovarian cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10070908 Term: Ovarian cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Cisplatino
Product Name: Cisplatino
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Paclitaxel
Product Name: Paclitaxel
Pharmaceutical Form: Concentrate for solutio
Sponsors
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia (FFIS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women aged between 18-70 years with a proven histological diagnosis of FIGO stage IIIB-C/IV epithelial ovarian cancer (high grade serous epithelial carcinoma). - Absence of extraperitoneal disease. - Good functional status: Karnofsky index >70 or Performance status =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Disease progression during systemic treatment with neoadjuvant chemotherapy. - Extraperitoneal disease (including retroperitoneal lymph node metastases). - Impossibility of achieving complete cytoreduction (CC-0), in the preoperative evaluation (imaging tests), or intraoperatively. - Conduct of at least one digestive anstomosis of any nature. - Active infection of any origin. - Allogeneic transplant, or previous bone marrow transplant, or high dose chemotherapy with bone marrow or stem cell rescue. - Beeing enrroled in a clinical trial with an investigational drug in the last 30 years. - Not having given writing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether the combined administration of HIPEC with CISPLATINO (100mgr/m2 body surface area) and postoperative bidirectional chemotherapy (intraperitoneal and systemic) after complete cytoreduction is feasible, effective and safe in patients with IIIB-C/IV ovarian cancer treated with systemic chemotherapy. neoadjuvant.;Secondary Objective: Evaluate patients' life quality before surgery, before the start of chemotherapy treatment and after its completion (3 and 6 months).;Primary end point(s): - The safety variable of the study will be postoperative Morbidity and Mortality. Morbidity will be defined based on the NCI-CTCAE v4 scale classification. Minor complications will be considered those that require only medical treatment for their resolution (grade II) and moderate complications those that require invasive procedures, such as percutaneous drainage guided by ECHO/CT, placement of a pleural drainage tube or therapeutic endoscopy (grade III) . Serious complications (grade IV) will be those that require a new surgical intervention or admission of the patient to the ICU for their resolution. Causes of death related to the procedure (mortality) will be those that occur before the patient's hospital discharge or within the first 30 days after hospital discharge. The causes of death will also be reflected. - The variables related to the treatment effectiveness will be disease-free and overall survival.;Timepoint(s) of evaluation of this end point: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary variable will be the patients' life quality once treatment finished, evaluated using the EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires.;Timepoint(s) of evaluation of this end point: 3-6 months | — |
Countries
Spain
Contacts
Public ContactMaria Muñoz
Plataforma EECC IMIB
Outcome results
None listed