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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 1 treatment group