NCT04282356 Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer

Eligibility & Interventions

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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.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 55 participants in total. It began in 2020-09-15 with a primary completion date of 2026-12.

Brief Summary

Clinicians postulate that it may be interesting to combine the two IntraPeritoneal (IP) treatments associated with a significant improvement of OC overall survival i.e. cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC) as an " intensive peritoneal " regimen in the initial management of stages III-IVA ovarian cancers. Performing a postoperative IPC may allow completing and extending the duration of the effect of HIPEC in decreasing the risk of peritoneal recurrence. HIPEC may also allow administering an early IP treatment on the residual microscopic disease during initial or interval surgery with an optimal access to the intraperitoneal cavity. Postoperative IPC will extend the HIPEC effect on unsterilized peritoneal microscopic residues with the aim of decreasing the risk of local recurrence. Performing HIPEC before IPC could allow limiting the number of postoperative IP courses needed. Nevertheless, this association questions its feasibility and tolerance, which should both be assessed in a phase II trial. Clinicians propose to conduct this feasibility study combining for the first time HIPEC with IPC as first-line treatment of ovarian cancer with peritoneal carcinomatosis to perform a peritoneal intensification.

Eligibility Criteria

Inclusion Criteria: * Patients aged 18 to 75 years, * Patients with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancer, * Initial laparoscopy confirming the histological type, evaluating the extent of the disease by PCI score and confirming the initial non-resectability, * Stage III B-C (FIGO 2014) or stage IVA with minimal or moderate pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is less than 3 cm), * Complete interval cytoreduction surgery, * Indication of 3 to 4 cures of neoadjuvant chemotherapy based on the Carboplatin-Paclitaxel (carbo-taxol) combination, * The delay between the last course of NAT and the surgery must be between 4 and 8 weeks, * Hematologic function, hemoglobin ≥ 10 g / dl; PNN ≥ 1 x 109 / L, platelets ≥ 100 x 109 / L, * Total bilirubin ≤ 1.5 LSN, ALT or AST ≤ 3 ULN, * Absence of renal insufficiency (creatinine clearance ≤ 70 ml / min) according to the MDRD method, * Informed consent signed before any specific procedure under consideration, * Patients affiliated to the French social security scheme or equivalent. Exclusion Criteria: * Performance Index (WHO) ≥ 2, * Stage IV B or IV A with significant pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is more than 3 cm), * Renal impairment (clearance \<70 ml / min) according to the MDRD method, * General contraindication to the realization of a tumor reduction surgery or HIPEC (contraindication or history allergic reaction to any treatments components), * Hepatic insufficiency (bilirubin \> 1.5 x normal, ASAT \& ALAT \> 3 x upper limit of normal), * Serious life-threatening co-existing condition at stake, * Cardio-respiratory pathology indicating hyper hydration, to be implemented for HIPEC, * Patient who has already been treated with chemo-hyperthermia for ovarian cancer, * History of cancer, except basal cell carcinoma of the skin or carcinoma in situ of cervix having recurred within five years prior to entry into this trial, * Any severe untreated infectious disease, * Peripheral sensory neuropathy ≥ grade 2 at the inclusion time, * Patients whose regular follow-up is a priori impossible for psychological, family, social or geographical reasons, * Pregnant and / or nursing women, * Subjects under tutelage, curatorship or safeguard of justice.

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