A multicenter, low-intervention, drug-based study to evaluate the feasibility and safety of a combined regimen of two intraperitoneal chemotherapy modalities (used in routine clinical practice) following interval surgery for the treatment of advanced ovarian cancer. This is an independent research project (free of commercial interests).
Women aged 18-70 years with a histologically proven diagnosis of FIGO stage IIIB-C/IV epithelial ovarian cancer (high-grade serous epithelial carcinoma)
Absence of extraperitoneal disease.
Good performance status: Karnofsky score >70 or Performance status <= 2
Adequate liver function, defined as bilirubin <0.15 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase <= 2.5 times ULN, and alkaline phosphatase <= 3 times ULN.
Disease progression during systemic treatment with neoadjuvant chemotherapy.
Extraperitoneal disease (including retroperitoneal lymph node metastases)
Inability to achieve complete cytoreduction (CC-0) during preoperative (imaging) or intraoperative evaluation.
Performance of at least one digestive anastomosis of any type. Active infection of any origin
Single group
Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstron
DrugFollowing 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, patients in the study will receive 4 cycles of 21 days every 3 weeks of the regimen studied by Armstrong 8 and modified by GEICO 18: IV paclitaxel 175 mg /m2 (day 1) + IP cisplatin 100 mg/m2 (day 2) + IP paclitaxel 60 mg/m2 (day 8).
Disease-free interval
Number of days without disease
Safety related to the intervention
Number of adverse events reported
Quality of life of the participants
To evaluate the Quality of Life parameters of patients before surgery, before the start of treatment and after its completion (3 and 6 months). EQ-5D SCALE, 20-centimeter vertical EVA, measured in millimeters, ranging from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
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