NCT06902467 Combined Intraperitoneal Chemotherapy Regimen After Optimal Interval Surgery in Advanced Ovarian Cancer: BICOV-1 (Bidirectional Chemotherapy in Ovarian Cancer)
| NCT ID | NCT06902467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2026-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-02-27 with a primary completion date of 2026-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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.
Contact & Investigator
Pedro Cascales Campos, MD
PRINCIPAL INVESTIGATOR
HCUVA
Frequently Asked Questions
Who can join the NCT06902467 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06902467 currently recruiting?
Yes, NCT06902467 is actively recruiting participants. Contact the research team at cascalescirugia@gmail.com for enrollment information.
Where is the NCT06902467 trial being conducted?
This trial is being conducted at Murcia, Spain.
Who is sponsoring the NCT06902467 clinical trial?
NCT06902467 is sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. The principal investigator is Pedro Cascales Campos, MD at HCUVA. The trial plans to enroll 20 participants.
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