About this trial
Ovarian cancer is the leading cause of gynecological cancer mortality, with no current screening method effective for early diagnosis, with 75% of advanced stage patients being detected. Not all patients are candidates for standard treatment, which is primary cytoreduction followed by adjuvant chemotherapy, due to the advanced process. A subgroup of patients will receive neoadjuvant chemotherapy followed by interval surgery, which allows higher rates of optimal cytoreduction with low morbidity and mortality. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a therapeutic option that is used in pathologies of peritoneal dissemination, whose morbidity and mortality has been reported in several series and is promising as a management option for ovarian cancer, so it is necessary to evaluate morbidity and mortality that conditions this modality of treatment as well as if it impacts on the quality of life of the patients to whom they are performed, which will allow offering our patients an option of additional treatment to the standard.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients younger than 70 years
Patient with a diagnosis of high grade serous carcinoma of the ovary and low-grade endometrioid corroborated by histopathological study.
Clinical stage IIIC and IVA (cytology-positive pleural effusion) who have received induction chemotherapy 3 or 4 cycles of CARBOPLATIN and PACLITAXEL.
Partial response to treatment with chemotherapy and evaluated by computed tomography (RECIST-see below) and response of at least 50% by serum determination of CA-125 antigen.
Disqualifiers
Patients with heart failure, ischemic heart disease
Previous history of treatment with chemotherapy for some other neoplasia
History of neuropsychiatric disease
Patients with intra operative bleeding that condition hemodynamic instability.
Trial design
Parallel
Treatments tested in this trial
HIPEC
Procedure/SurgeryFollowing complete cytoreductive surgery without any evidence of residual disease, the patient will be randomized either HIPEC (intervention) or no-HIPEC (control) in the operative Room. If the arm HIPEC is obtained, then a HIPEC procedure with cisplatin and doxorubicin will be performed. If no-HIPEC (control arm) is assigned then the surgical procedure will be finished.
Treatment groups
Trial outcomes
Primary outcomes
Mortality
To assess the mortality associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.
Impact of quality of life
To evaluate the impact on patients' quality of life, which is undergoing intraperitoneal hyperthermic chemotherapy during interval laparotomy. The scales that will be used will be EORTC QLQ-C30 (Ver. 3) and EORTC QLQ-OV28.
Morbility
To assess the morbidity associated with the use of intraperitoneal hyperthermic chemotherapy during interval laparotomy.
Secondary outcomes
Disease free survival
Evaluate disease-free survival.
Overall survival
Evaluate overall 5 year survival.
Sponsors and contacts
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