Condition: Peritoneal Carcinomatosis · Ovarian Cancer · Sponsor: Oncoinvent Solutions AS
This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin® in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS. The study will be conducted in 2 parts; first, a Safety Lead-in Cohort will be recruited followed by the randomised part of the study. For both parts of the study, patients must be scheduled to undergo NACT and IDS and complete resection to no residual tumour (R0) should be deemed to be achievable during diagnostic work-up. Patients in both parts of the study will undergo the same procedures and assessments.
This description comes directly from the study's public registry record.
Anne-Kirsti Aksnes, PhD · 004722183305 · aksnes@oncoinvent.com
Trine Jensen Gjertsen · 004722183305 · gjertsen@oncoinvent.com
Always discuss trial participation with your own doctor first.
| Moffitt Cancer Center | Tampa, Florida, United States | Recruiting |
| UZ Leuven | Leuven, Belgium | Recruiting |
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma, Italy | Recruiting |
| The Norwegian Radiumhospital | Oslo, Norway | Recruiting |
| Hospital Universitari de Bellvitge | Barcelona, Spain | Recruiting |
| Clinica Universidad de Navarra | Madrid, Spain | Recruiting |
| Clinica Universidad de Navarra | Pamplona, Spain | Recruiting |
| Hospital Universitari i Politècnic La Fe | Valencia, Spain | Recruiting |
| Imperial College Healthcare NHS Trust | London, United Kingdom | Recruiting |
| University Hospital Southampton NHS Foundation Trust | Southampton, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06504147