Intraperitoneal chemotherapy for advanced ovarian cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hcuva
  Murcia, Spain Recruiting

Study contacts

• Principal investigator: Pedro Cascales Campos, MD — Hcuva
• Study coordinator: Pedro Cascales Campos, MD
• Email: cascalescirugia@gmail.com
• Phone: 968369500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.