NCT06902467

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	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	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).

Timeline

• Start date: 2023-02-27
• Primary completion: 2026-03-15
• Completion: 2026-12-15
• First posted: 2025-03-30
• Last updated: 2025-03-30

Locations

1 site across 1 country: Spain