At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Radspherin (drug)
- How long the study runs
- Study runs about 80 months (dates as stated)
- About the drug or intervention
- Radspherin — drug: Radspherin® suspension consists of bio-degradable calcium carbonate micro particles with the α-emitting radionuclide 224Ra in suspension.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at Radspherin® for women with advanced ovarian, fallopian tube, or primary peritoneal cancer that has spread to the lining of the abdomen (the peritoneum). It is for patients whose cancer is 'homologous recombination proficient', meaning a specific repair pathway in the cancer cells still works normally. Participants are due to have chemotherapy before surgery (called neoadjuvant chemotherapy) followed by an operation to remove the cancer (called interval debulking surgery).
Who can take part
- Women aged 18 or over who can give written consent and follow the study plan
- Diagnosis of advanced high-grade serous or high-grade endometrioid cancer of the ovary, fallopian tube, or peritoneum (FIGO stage IIIB/C or IV — FIGO is a system that describes how far the cancer has spread)
- Cancer spread within the abdomen that the surgeon believes can be fully removed during the planned operation
- Cancer confirmed as 'homologous recombination proficient' (HR proficient)
- Already had chemotherapy before surgery, with scans showing the cancer has shrunk or stayed stable, and assessed as operable with no tumour left behind
- Well enough for surgery and further treatment, with an ECOG performance status score of 0 to 2 (a measure of how well and active you are)
- Healthy enough kidneys, liver, and blood counts, shown by blood tests
- A negative pregnancy test before joining, for women who can still become pregnant, plus agreement to use highly effective contraception during treatment and for at least 9 months after receiving Radspherin® (unless the womb or ovaries are removed during surgery)
Who may not be able to
- Known BRCA1 or BRCA2 gene changes (mutations), or cancer confirmed as 'homologous recombination deficient'
- Possible leak or shunt in the abdomen, based on the doctor's judgement, your history, or scans
- Certain other types of ovarian tumours, or cancer that has come back after earlier treatment
- Cancer spread to the brain or spinal cord causing symptoms
- Another cancer in the past 3 years, with a few exceptions such as some skin cancers
- Previous radiotherapy to the abdomen or pelvis
- Cancer that got worse during the chemotherapy given before surgery
- Pregnancy or breastfeeding
- Active infection needing antibiotics or monitoring, or a fever over 38°C with an infection
- Active liver disease, or positive tests for hepatitis B, hepatitis C, or HIV
- Serious heart failure now or in the past (NYHA class III/IV — a scale for heart failure severity)
- Any other condition or illness that, in the study doctor's view, could affect your safety or the study results, or that would stop you following the study plan
- Taking another experimental medicine recently (within 4 weeks or 5 times its half-life)
- Having other cancer treatment within 4 weeks before or up to 4 weeks after the surgery
- Treatment with a medicine called bevacizumab within 5 weeks before the surgery
- Known severe allergy to any of the other ingredients in the study drug
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team. Taking part involves receiving Radspherin® around planned chemotherapy and surgery, using effective contraception for at least 9 months afterwards if applicable, and following the study plan.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 114
- Started
- 2024-06-15
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for peritoneal carcinomatosis
- • Phase2 - 114 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with peritoneal carcinomatosis
- • Female only
Where?
- • London - Imperial College Healthcare NHS Trust
- • Southampton - University Hospital Southampton NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
Biomarkers mentioned
What the study is looking for
- ✓Able and willing to provide written agreement to take part and to comply with the clinical study protocol (CSP).
- ✓Female of age ≥ 18 years.
- ✓Patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or...
- ✓Peritoneal and other metastases eligible for IDS to no residual tumour.
- ✓Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for...
Who cannot take part
- ✗Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient.
- ✗Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on...
- ✗causing symptoms central nervous system metastasis.
- ✗Prior abdominal/pelvic radiotherapy.
- ✗Disease progression during NACT.
See the full criteria
Where Is This Study? (2 UK sites)
Imperial College Healthcare NHS Trust
London, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
How to Get in Touch
Anne-Kirsti Aksnes, PhD
Sponsor contactCONTACT
Trine Jensen Gjertsen
Sponsor contactCONTACT
