Radspherin (radium-224) in peritoneal metastasis in ovarian cancer
Research type
Research Study
Full title
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
IRAS ID
1008976
Contact name
Stian Brekke
Contact email
Sponsor organisation
Oncoinvent AS
Research summary
This is a clinical phase 2 study to evaluate the efficacy & safety of Radspherin® in patients with peritoneal spread from ovarian, fallopian tube or primary peritoneal cancer, (hereafter referred to as ovarian cancer) after complete surgical resection (referred to as interval debulking surgery) following pre-operative chemotherapy. A negative test for HRD (homologous recombination deficiency) will be used to select patients for inclusion, as these patients benefit less from current available treatment options. The aim of Radspherin® treatment is to deliver alpha radiation to non-visible tumour cells in the peritoneal cavity that often remain after surgical treatment. Untreated, these tumour cells may colonize and give rise to tumour recurrence and disease progression. By eradicating these cells, it is possible that the patients can remain cancer-free longer and potentially survive longer after treatment. The study is designed to compare the efficacy and safety between patients who receive Radspherin® after complete surgical resection following pre-op chemotherapy (experimental group) and patients who only undergo pre-op chemotherapy and surgery (control group). There is a lead-in safety part, where all patients (6-12) will receive Radspherin®. If the safety profile of the treatment is found acceptable after this part, the study will continue with a part where patients are assigned by chance to either the experimental group (around 68 patients) or the control group (around 34 patients). Randomisation will take place the week prior to surgery and both patient and physician will be informed which treatment group they are assigned to. Patients receiving Radspherin®, will receive this via injection into the peritoneal cavity through a catheter that is placed during surgery. Patients will be followed closely for 4 weeks after surgery, then regular follow-ups, including clinical exams, bloods, imaging every 3 months upto 2yrs, then collecting info for 3yrs
REC name
North West - Haydock Research Ethics Committee
REC reference
23/NW/0381
Date of REC Opinion
26 Jan 2024
REC opinion
Further Information Favourable Opinion