Intraperitoneal chemotherapy for advanced ovarian cancer after surgery

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

This study is testing a new way to give chemotherapy directly into the abdomen after surgery for advanced ovarian cancer to see if it helps patients live longer with fewer side effects.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Murcia)
• Trial ID: NCT06902467 on ClinicalTrials.gov

What this trial studies

This multicenter study evaluates the feasibility and safety of a combined regimen of two intraperitoneal chemotherapy modalities following optimal interval surgery for advanced ovarian cancer. The approach involves administering 4 cycles of chemotherapy after patients have undergone neoadjuvant chemotherapy and complete interval surgery. The study aims to minimize complications and toxicity associated with intraperitoneal treatment while maximizing disease-free survival for patients. It is an independent research project free of commercial interests.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-70 with FIGO stage IIIB-C/IV high-grade serous epithelial ovarian cancer and no extraperitoneal disease.

Not a fit: Patients with extraperitoneal disease or those with significant comorbidities that contraindicate major surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve disease-free survival rates for women with advanced ovarian cancer.

How similar studies have performed: Previous studies have shown promise with similar intraperitoneal chemotherapy approaches, suggesting potential for success in this study.

Eligibility criteria

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.

Where this trial is running

Murcia

• HCUVA — Murcia, Spain (RECRUITING)

Study contacts

• Principal investigator: Pedro Cascales Campos, MD — HCUVA
• Study coordinator: Pedro Cascales Campos, MD

Conditions: Ovarian Cancer