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Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer

Study acronym: INTENS-IP
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv6
  2. Notable Primary completion date: Dec 2021 to Dec 2026
    • Study completion date: Dec 2026 to Dec 2030
    v5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2020 to Sep 15, 2020
    • Site details revised
    v3
  5. Notable Start date: Mar 2020 to Sep 2020v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04282356
Lead Sponsor Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators: Direction Générale de l'Offre de Soins
Conditions
(from sponsor)
Ovarian Cancer, Intraperitoneal Chemotherapy
Related terms Ovarian Neoplasms
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov