A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery (NCT06504147)
A Phase 2, Randomised, Open Label, Multicentre Study of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Primary Advanced High-grade Serous or High-grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient and Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Moffitt Cancer Center — Tampa, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- Moffitt Cancer Center — Tampa, Florida
- UZ Leuven — Leuven,
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma,
- The Norwegian Radiumhospital — Oslo,
- Hospital Universitari de Bellvitge — Barcelona,
- Clinica Universidad de Navarra — Madrid,
- Clinica Universidad de Navarra — Pamplona,
- Hospital Universitari i Politècnic La Fe — Valencia,
- Imperial College Healthcare NHS Trust — London,
- University Hospital Southampton NHS Foundation Trust — Southampton,
📞 Contact the Study Coordinator
Phone: 004722183305
Email: aksnes@oncoinvent.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC — Lexington, Kentucky
- Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC) — Montreal, Quebec
- Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis — Orange, California
Explore by condition: All Peritoneal Carcinomatosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.