Combined Intraperitoneal Chemotherapy Regimen After Optimal Interval Surgery in Advanced Ovarian Cancer: BICOV-1 (Bidirectional Chemotherapy in Ovarian Cancer)

Inclusion Criteria:

• Women aged 18-70 years with a histologically proven diagnosis of FIGO stageIIIB-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, andalkaline phosphatase <= 3 times ULN.

• Adequate renal function, defined as serum creatinine <= 1.5 times ULN

• Acceptable bone marrow function, defined as neutrophils >1.5 x 106 L-1, hemoglobin >10 g/dL-1, and platelets >100.0 x 109 L-1

• Absence of cardiac, pulmonary, hepatic, renal, or neurological disease thatcontraindicates major surgery.

• Negative serum and urine pregnancy test results for women of childbearing potentialat the screening visit.

• Administration of neoadjuvant chemotherapy with a total of 3 or 4 systemic cycles.

• Surgery with complete CC0 cytoreduction without digestive anastomoses.

• Patients who have signed the written IC.

Exclusion Criteria:

• 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) orintraoperative evaluation.

• Performance of at least one digestive anastomosis of any type. Active infection ofany origin

• Allogeneic transplant, or prior bone marrow transplant, or high-dose chemotherapywith bone marrow or stem cell rescue.

• Participation in a clinical trial with an investigational drug within the last 30days.

• Pregnant or breastfeeding women, where pregnancy is defined as the state of a womanafter conception and until the end of pregnancy, confirmed by a positive humanchorionic gonadotropin (hCG) test result, or who plan to become pregnant orbreastfeed during study treatment or within 30 days of the end of treatment with thestudy drug.

• Patients with a history of allergic reactions or hypersensitivity to drugschemically related to cisplatin and paclitaxel.

• Failure to sign written informed consent.