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

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).

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro Cascales Campos, MD; Phone Number: 968369500; Email: cascalescirugia@gmail.com

Study Locations

• Spain
  • Murcia, Spain, 30120
    • Recruiting
    • HCUVA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• 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 that contraindicates major surgery.
• Negative serum and urine pregnancy test results for women of childbearing potential at 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) or intraoperative evaluation.
• Performance of at least one digestive anastomosis of any type. Active infection of any origin
• Allogeneic transplant, or prior bone marrow transplant, or high-dose chemotherapy with bone marrow or stem cell rescue.
• Participation in a clinical trial with an investigational drug within the last 30 days.
• Pregnant or breastfeeding women, where pregnancy is defined as the state of a woman after conception and until the end of pregnancy, confirmed by a positive human chorionic gonadotropin (hCG) test result, or who plan to become pregnant or breastfeed during study treatment or within 30 days of the end of treatment with the study drug.
• Patients with a history of allergic reactions or hypersensitivity to drugs chemically related to cisplatin and paclitaxel.
• Failure to sign written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Following 3 or 4 cycles of systemic neoadjuvant chemotherapy and complete interval CC-0 surgery, pat; 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).

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free interval	Number of days without disease	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety related to the intervention	Number of adverse events reported	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).	Up to 5 years

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Investigators: Principal Investigator: Pedro Cascales Campos, MD, HCUVA

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Genital Diseases, Female; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Carcinoma; Carcinoma, Ovarian Epithelial; Ovarian Neoplasms
• Other Study ID Numbers: IMIB-BICOV-2022-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No