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 study about?

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.

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 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 surgical assessment

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

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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Oslo Universitetssykehus HF Oslo Norway
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital Del Mar Barcelona Spain
Hrfhblcb Vzcc dnstbwxk Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.04.2024
Italy Italy
Recruiting
01.04.2024
Norway Norway
Recruiting
01.04.2024
Spain Spain
Recruiting
01.04.2024

Trial locations

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.

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 ID:
2023-508497-28-00
Trial Phase:
Therapeutic exploratory (Phase II)

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