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Study of Radium-224 in Patients with Advanced Ovarian, Fallopian Tube, or Peritoneal Cancer with Peritoneal Metastasis Undergoing Chemotherapy and Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying certain types of advanced cancers that affect the ovaries, fallopian tubes, or the lining of the abdomen, known as the peritoneum. These cancers are specifically referred to as high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study is investigating a treatment called Radspherin, which is a type of therapy that involves injecting a special substance into the abdominal area. This substance contains radium-224, a radioactive element, which is absorbed in tiny particles of calcium carbonate. The aim is to see if this treatment can help patients who are scheduled to receive chemotherapy and surgery to remove as much of the cancer as possible.

The purpose of the study is to compare how long patients can live without their cancer getting worse when treated with Radspherin compared to those who do not receive this treatment. Patients participating in the study will be randomly assigned to either receive the treatment or not. The study will follow their progress over time to see how the treatment affects their cancer. This includes regular check-ups and imaging tests like CT or MRI scans to monitor the cancer's status.

Throughout the study, researchers will also look at other factors, such as overall survival rates, the time until further cancer treatment is needed, and changes in certain cancer markers in the blood. Additionally, the study will assess how the treatment impacts patients' quality of life through questionnaires. The goal is to gather comprehensive data to understand the potential benefits and effects of Radspherin in treating these advanced cancers.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    Upon joining the study, the patient provides written informed consent, confirming understanding and willingness to comply with the study protocol.

    Eligibility is confirmed through specific tests, including Myriad MyChoice CDx testing to ensure homologous recombination proficiency.

  2. Step 2

    Initial treatment phase

    The patient undergoes 3 or 4 cycles of neoadjuvant chemotherapy (NACT).

    Progress is monitored through diagnostic imaging to ensure the disease is stable or regressing.

  3. Step 3

    Surgical assessment

    The patient's condition is assessed to determine operability for interval debulking surgery (IDS) with the goal of no residual tumor.

  4. Step 4

    Randomization and treatment

    The patient is randomly assigned to receive either the investigational treatment or no additional treatment.

    If assigned to the treatment group, the patient receives Radspherin, a suspension for injection containing radium-224 adsorbed in calcium carbonate microparticles, administered intraperitoneally.

  5. Step 5

    Post-treatment monitoring

    Progression-free survival (PFS) is monitored using computed tomography (CT) or magnetic resonance imaging (MRI) according to specific criteria.

    Additional assessments include overall survival (OS), progression in the peritoneum (PPFS), and time to subsequent therapies (TFST and TSST).

  6. Step 6

    Quality of life assessment

    Changes in quality of life are evaluated using specific forms from the European Organization for Research and Treatment of Cancer (EORTC).

    Biomarker levels, such as CA125, are also monitored for changes from baseline.

Who can join the trial?

13 criteria

  • The patient must be able and willing to provide written consent and follow the study rules.
  • The patient must have a confirmed **HR proficient** status, which means their cancer cells have a specific characteristic, confirmed by a test called Myriad MyChoice CDx.
  • The patient must have completed 3 or 4 cycles of **NACT** (a type of chemotherapy) with either a reduction or no change in the disease, and the disease must be operable to remove all visible tumors.
  • The patient must have an **ECOG Performance Status Score** of 0 to 2, indicating they are fit enough for surgery and further treatment.
  • The patient must have adequate kidney function, with a creatinine clearance of at least 40 ml/min, which is a measure of how well the kidneys are working.
  • The patient must have adequate liver function, with specific levels of **serum bilirubin** and liver enzymes (aspartate transaminase and alanine transaminase) within normal limits.
  • The patient must have adequate bone marrow function, with specific levels of **neutrophils**, **platelets**, and **hemoglobin** in the blood.
  • If the patient is a female of childbearing potential, a negative pregnancy test is required before joining the study.
  • Females of childbearing potential must agree to use highly effective birth control methods during the study and for at least 9 months after treatment, unless they have had certain surgeries like hysterectomy or oophorectomy.
  • The patient must be a female aged 18 years or older.
  • The patient must have a specific type of advanced cancer, such as high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, at certain stages (FIGO Stage IIIB/C or IV).
  • The patient must have peritoneal and other metastases that can be surgically removed to leave no visible tumor.
  • Any side effects from previous cancer treatments must have improved to at least a mild level, except for hair loss.

Who cannot join the trial?

3 criteria

  • Patients with **carcinomatosis of the peritoneal cavity** cannot participate. This means cancer has spread to the lining of the abdomen.
  • Only **female** patients are eligible, so male patients cannot participate.
  • Patients who are part of a **vulnerable population** are not eligible. This generally refers to groups who may need special protection or care.
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Investigated drugs

Radspherin® is an intraperitoneal therapy that uses a type of radiation called α-emitting radionuclide. It is being studied for its potential to treat patients with certain types of advanced ovarian, fallopian tube, or primary peritoneal cancer. This therapy is specifically for patients whose cancer has spread to the lining of the abdomen and who are scheduled to receive chemotherapy and surgery. The goal of using Radspherin® in this trial is to see if it can help patients live longer without their cancer getting worse.

What is already known about the treatment

Radspherin – This medication is administered intraperitoneally, meaning it is delivered directly into the abdominal cavity. It is currently being studied in clinical trials for its effectiveness in treating certain types of advanced ovarian, fallopian tube, and primary peritoneal cancers with peritoneal metastasis. The main therapeutic indication is for patients with these cancers who are homologous recombination proficient. Radspherin works by emitting alpha particles that target and destroy cancer cells at the molecular level. It is classified as a radionuclide therapy, which is a type of targeted cancer treatment.

Investigated diseases

Carcinomatosis of peritoneal cavity – This condition involves the spread of cancer cells to the lining of the abdominal cavity, known as the peritoneum. It often occurs as a result of advanced cancers, such as ovarian, stomach, or colon cancer. The disease progresses as cancer cells implant and grow on the peritoneal surfaces, leading to the formation of multiple tumor nodules. This can cause the peritoneal cavity to fill with fluid, a condition known as ascites, which may lead to abdominal swelling and discomfort. As the disease advances, it can interfere with the function of abdominal organs, leading to symptoms such as nausea, vomiting, and changes in bowel habits. The progression of the disease can vary depending on the type and aggressiveness of the primary cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508497-28-00Estimated enrolment107 patientsSponsorOncoinvent Solutions AS

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).