Study of Radspherin® for Patients with Peritoneal Cancer from Colorectal Cancer After Surgery and Chemotherapy

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What is this study about?

This clinical trial is focused on studying a condition known as peritoneal carcinomatosis, which occurs when cancer cells spread to the lining of the abdominal cavity. This condition is often associated with colorectal cancer, a type of cancer that begins in the colon or rectum. The trial will investigate the effects of a treatment called Radspherin, which is a suspension for injection containing radium-224 adsorbed in calcium carbonate microparticles. This treatment is designed to be administered directly into the abdominal cavity, a method known as intraperitoneal use.

The purpose of the study is to compare the time patients live without their disease getting worse after receiving Radspherin compared to those who do not receive this treatment. Participants in the study will have undergone a procedure called cytoreductive surgery, which aims to remove as much of the tumor as possible, followed by hyperthermic intraperitoneal chemotherapy (HIPEC), a treatment that involves heating chemotherapy drugs and delivering them directly into the abdominal cavity. The study will follow participants over a period of time to monitor their health and any changes in their condition.

Throughout the study, participants will undergo regular assessments, including imaging tests like CT or MRI, to evaluate the progression of their disease. The study will also track overall survival, changes in specific blood markers, and any side effects experienced by participants. The goal is to gather information on the safety and effectiveness of Radspherin in treating peritoneal carcinomatosis from colorectal cancer.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Written informed consent is required to participate.

For females of childbearing potential, a negative pregnancy test must be documented before enrollment. Both male and female participants must agree to use effective contraception during the treatment period and for a specified time afterward.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying a diagnosis of colorectal carcinoma with peritoneal metastases and ensuring adequate organ function.

The patient’s performance status will be evaluated using the Eastern Cooperative Oncology Group (ECOG) scale, and laboratory tests will be conducted to assess renal, hepatic, and bone marrow function.

3 treatment administration

The treatment involves the administration of Radspherin, a suspension for injection containing radium-224 adsorbed in calcium carbonate microparticles.

The medication is administered intraperitoneally, meaning it is injected into the abdominal cavity. The exact dosage and frequency will be determined by the study protocol.

4 monitoring and follow-up

The patient will be monitored for progression-free survival (PFS), which is the time from randomization until disease progression or death.

Regular assessments using imaging techniques like CT or MRI will be conducted to evaluate the response to treatment according to established criteria.

Secondary outcomes such as overall survival (OS), changes in biomarkers, and quality of life will also be monitored.

5 completion and evaluation

The study is expected to continue until March 2031. Upon completion, the patient’s data will be analyzed to assess the efficacy and safety of the treatment.

The incidence and severity of any adverse events will be recorded and evaluated throughout the study period.

Who Can Join the Study?

Must be able and willing to provide written consent and follow the study rules.
Females who can have children must have a negative pregnancy test before joining.
Females who can have children must agree to use a highly effective birth control method during the study and for at least 9 months if they receive the treatment. This includes options like:
- Female sterilization (surgical removal of ovaries or uterus, or tying of fallopian tubes).
- Use of hormonal birth control methods like pills, injections, implants, or devices placed inside the uterus.
Non-sterile males with female partners who can have children must agree to use condoms during the study and for at least 6 months if they receive the treatment. The female partner should also use a highly effective birth control method.
Non-sterile males must agree not to donate sperm during the study and for up to 6 months after receiving the treatment.
Must be 18 years or older.
Must have a confirmed diagnosis of colorectal cancer. If the cancer has returned and spread to the peritoneal cavity, a biopsy during surgery is acceptable to confirm this.
Must have peritoneal metastases that can be surgically removed with the goal of leaving no visible tumor.
Any side effects from previous cancer treatments must have improved to at least a mild level, except for hair loss.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 to 1, which means being fully active or having some symptoms but being able to carry out light work.
Must have adequate kidney function, with a creatinine clearance of at least 40 ml/min.
Must have adequate liver function, with serum bilirubin less than 1.5 times the normal limit, and liver enzymes (AST and ALT) no more than 3 times the normal limit.
Must have adequate bone marrow function, with a certain level of white blood cells, platelets, and hemoglobin.

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country	Status
Netherlands Cancer Institute	Amsterdam	The Netherlands
Ugnoqxl Uwxyrnzubf Hjvxtzje	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Norway	Not yet recruiting	01.12.2027
Sweden	Not yet recruiting	01.12.2027
The Netherlands	Not yet recruiting	01.12.2027

Trial locations

Investigated drugs:

Radium-224 Adsorbed In Calcium Carbonate Microparticles

Radspherin® is a type of therapy that uses a radioactive substance to target cancer cells. In this trial, it is used to treat patients with cancer that has spread to the lining of the abdomen from colorectal cancer. The treatment is given directly into the abdominal cavity after surgery to remove as much of the cancer as possible and after a special type of chemotherapy that is heated and also given directly into the abdomen. The goal of Radspherin® is to help stop the cancer from growing and spreading further.

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 originates from primary tumors in organs such as the colon, stomach, or ovaries. As the disease progresses, cancer cells implant on the peritoneal surface, leading to the formation of multiple small tumors. This can cause the peritoneum to thicken and produce excess fluid, resulting in abdominal swelling and discomfort. Over time, the accumulation of cancerous cells can interfere with normal organ function within the abdominal cavity. The progression of the disease can vary depending on the primary cancer type and individual patient factors.

Trial ID:

2023-508496-37-00

Protocol code:

RAD-18-004

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Radspherin® for Patients with Peritoneal Cancer from Colorectal Cancer After Surgery and Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?