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).
Based on the available evidence, an optimized protocol is proposed for the radical approach to primary advanced ovarian cancer with peritoneal dissemination (FIGO III/IV). After optimal interval surgery defined as CRS + HIPEC, bidirectional therapy (BIC) will be evaluated, reproducing the scheme studied by Armstrong 8 with the modifications and recommendations of GEICO (Spanish Ovarian Cancer Research Group) 18. A series of measures are proposed to minimize the risk of complications and toxicity related to intraperitoneal treatment. All of this, with the ultimate objective of maximizing the patient's disease-free survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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 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).
HCUVA
Murcia, Spain
RECRUITINGDisease-free interval
Number of days without disease
Time frame: Up to 5 years
Safety related to the intervention
Number of adverse events reported
Time frame: Up to 5 years
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).
Time frame: Up to 5 years
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