Not yet recruitingPHASE2INTERVENTIONAL

Cabo-POLARIS : A Trial to Evaluate Cabozantinib Among Haemodialysied Patients

This study, called Cabo-POLARIS, is investigating a medication called cabozantinib for people with kidney cancer who are also receiving dialysis. Many kidney cancer treatments haven't been thoroughly tested in patients on dialysis because they are often excluded from major clinical trials. This means we don't have enough clear information on how safe or effective these treatments might be for them. This study aims to fill that gap by gathering important information about cabozantinib in this specific group. Participants will receive cabozantinib, provide blood samples, and fill out questionnaires about their quality of life, helping doctors understand if this treatment can improve care for kidney cancer patients on dialysis.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

Start

01 Jun 2022

Estimated completion

01 Mar 2027

Cancer of Kidney

What is this study about?

When someone has kidney cancer and also needs regular dialysis, it can be really difficult to find the best treatment options. Many of the standard cancer drugs haven't been properly tested in people who are on dialysis. This is because these individuals are often not allowed to join the large studies that check how well new drugs work.

This gap means doctors don't have clear guidance on how safe and effective certain kidney cancer medicines are for patients on dialysis. We know that being on dialysis can sometimes cause problems that are similar to the side effects of some cancer drugs, such as blood clots or high blood pressure. This study is designed to carefully look at a specific cancer drug called cabozantinib in this group of patients.

The main goal of the Cabo-POLARIS study is to understand if cabozantinib is a safe and helpful treatment for kidney cancer when someone is also on dialysis. By gathering this important information, the research hopes to improve the care and treatment choices available for people living with both kidney cancer and kidney failure.

Key takeaways

This study helps understand a kidney cancer drug (cabozantinib) for patients on dialysis.
People on dialysis are often not included in other drug trials, so this research is important.
It aims to find out if cabozantinib is safe and works well in this specific group.
Participants will take the drug, have blood tests, and complete questionnaires.
The findings could improve future treatment choices for kidney cancer patients on dialysis.

Who may be eligible?

To be considered for this study, you would need to have been diagnosed with an advanced form of kidney cancer that has spread. Your kidney cancer must specifically be either 'clear-cell' or 'papillary' type. You must also have already received at least one other treatment for your cancer.

A really important part of this study is that you need to have been receiving haemodialysis (a type of kidney dialysis) for at least three months. You should also be generally well enough to take part, with your doctor agreeing that it's safe for you. Participants must be 18 years or older and able to get around and do most of their daily activities without too much difficulty.

There are also reasons why someone might not be able to join. For example, if you've already had the study drug, cabozantinib, or certain other cancer drugs very recently. You also can't have had major surgery or radiotherapy shortly before the study starts. If your kidney cancer isn't the clear-cell or papillary type, or if you have certain types of brain tumours that aren't stable, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have advanced kidney cancer (clear-cell or papillary type)?
Have I already had at least one other cancer treatment?
Have I been on haemodialysis for at least three months?
Am I 18 years old or older and generally able to perform daily activities?
Have I NOT had cabozantinib before or certain other recent treatments/surgeries?
Is my doctor confident that taking part is suitable and safe for me?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, cabozantinib. You would have regular appointments with the study team to monitor your health and how you're responding to the treatment. These appointments will involve blood tests so doctors can check how the drug is affecting your body. You will also be asked to fill out questionnaires to share how you're feeling and how the treatment is impacting your quality of life. The total duration of your participation would be discussed in detail by the study team, including how often you would need to visit and for how long.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is to help doctors learn more about how cabozantinib works for kidney cancer patients on dialysis, which could improve future treatments for people like you. However, there's no guarantee the treatment will work for you, and there might be side effects from the medication. Your doctor will explain all known risks. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Centre Hospitalier Universitaire de Besançon
Verified postcode
Besançon, France

Common questions

What is cabozantinib?

Cabozantinib is a medication used to treat certain types of cancer. It works by blocking specific signals that cancer cells need to grow and spread.

Why are dialysis patients specifically being studied?

Patients on dialysis are often not included in major drug studies, so doctors don't have enough information on how safe or effective many cancer treatments are for them. This study aims to fill that knowledge gap for kidney cancer patients on dialysis.

Will my dialysis schedule change if I join?

The study aims to fit around your existing dialysis treatment. Any potential changes or interactions will be thoroughly discussed with you by the study team.

What will be asked of me during the study?

You will take the study medication, have regular health check-ups, provide blood samples, and complete questionnaires about your well-being and quality of life.

What are the common side effects of cabozantinib?

Common side effects can include tiredness, diarrhoea, feeling sick, and changes in blood pressure. Your study team will discuss all possible side effects with you.

How to find out more

Elise Robert

e1robert@chu-besancon.fr +33 3 81 66 81 66 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.