Clinical Trial

Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer

Study acronym: INTENS-IP
Recruiting Phase 2
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-02-21; most recent amendment 2025-02-11.
Status change: Not Yet Recruiting → Recruiting 2020-11-06
Trial Details
NCT Number NCT04282356
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators: Direction Générale de l'Offre de Soins
Conditions Ovarian Cancer, Intraperitoneal Chemotherapy
Enrollment 55 participants
Start Date 2020-09-15
Primary Completion 2026-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2025-02-12