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RecruitingPHASE2INTERVENTIONAL

A Phase II Study Assessing Stereotactic Radiotherapy in Therapeutic Strategy of Oligoprogressive Renal Cell Carcinoma Metastases

This study is investigating a new way to treat kidney cancer that has spread, specifically when only a few small areas of the cancer start to grow again while the rest is under control. This is called 'oligoprogression'. Instead of changing to a new, different medicine, researchers want to see if a very targeted radiation treatment, called stereotactic radiotherapy, can zap these growing spots. The idea is that by getting rid of these problematic areas, patients might be able to continue their current medication for longer. This could help delay the need for stronger treatments later and improve their quality of life. The study aims to gather more clear evidence on how effective and safe this approach is.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Centre Francois Baclesse
Enrolment target
77
Start
01 Jul 2020
Estimated completion
01 Aug 2029

What is this study about?

Kidney cancer can sometimes spread to other parts of the body, which doctors call metastatic cancer. When this happens, patients usually take medicines like targeted therapies or immunotherapy to help control the cancer. These treatments often work well for a while, but eventually, the cancer can start to adapt and grow again.

Sometimes, the cancer doesn't grow everywhere. Instead, only a few small, specific spots might start to get bigger or appear. This is called 'oligoprogression'. Up until now, when this happened, the usual approach was to switch to a different, often stronger, type of medicine. However, doctors are now exploring if there's another way to deal with these few growing spots without changing all the patient's medication.

This study explores using a very precise type of radiation called stereotactic radiotherapy (SRT) for these specific growing cancer spots. SRT delivers a very high dose of radiation directly to the tumour in just one or a few sessions, aiming to destroy it. The goal is to see if treating only these few problem areas with SRT can help patients stay on their current, effective medication for longer, delay the need for new systemic treatments, and potentially improve their quality of life. This research aims to provide clearer evidence about how well this method works and if it's a good option for people with kidney cancer.

Key takeaways

  • Looks at treating specific growing kidney cancer spots with targeted radiation.
  • Aims to help patients stay on their current cancer medicine longer.
  • Focuses on a situation called 'oligoprogression' (few growing spots).
  • Uses stereotactic radiotherapy, a precise high-dose radiation.
  • Could delay the need for new, different cancer treatments.
  • This is a Phase II study, exploring effectiveness and safety.

Who may be eligible?

To be able to join this study, you would need to have kidney cancer that has been confirmed by a biopsy. The cancer must have spread to other parts of your body, but not to your brain. You should be in generally good health and already receiving your first or second type of medicine (like targeted therapies or immunotherapy) for your cancer.

The most important part is that your cancer must show 'oligoprogression'. This means that while you're on your current medicine, only a small number of new spots (1 to 3) have started to grow, or a few existing spots have gotten bigger in no more than two different organs. These growing spots must be small enough (4cm or less) and in places where they can be safely treated with the special radiotherapy. This situation needs to be confirmed by two separate scans about two months apart. You also can't have received too many different types of cancer treatment before.

There are also some reasons why you might not be able to join. For example, if you have more than three growing spots, or if any of those spots are too big (over 4cm), or if they are in your brain or certain very sensitive areas like the middle of your lungs or a major long bone. You also can't participate if you've already had radiation to the specific spots that are now growing, or if you're pregnant or breastfeeding.

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.

  1. Do I have kidney cancer that has spread?
  2. Am I currently on my first or second line of cancer medicine?
  3. Have my scans shown only a few new or growing cancer spots (1-3) in one or two organs?
  4. Are these growing spots small (4cm or less) and reachable by radiation?
  5. Do I feel generally well (WHO performance status 0-2)?
  6. Do I have any other major uncontrolled health problems?
Answer every question to see your result.

What does participation involve?

The study aims to evaluate the effect of stereotactic radiotherapy on certain growing cancer spots while you continue your current systemic treatment. This will involve regular imaging scans (like CT scans) to monitor your cancer. If you are found to have the specific 'oligoprogression' targeted by the study, you would receive the stereotactic radiotherapy to those specific spots. You would also have regular appointments with your doctors to check on your health and how you are responding to the treatments. The total duration of your participation in the study would depend on how your cancer responds to treatment and how long you are able to continue your assigned treatments.

Potential risks and benefits

Participating in this study might offer the potential benefit of allowing you to continue your current effective systemic treatment for a longer period, possibly delaying the need to switch to a new type of medicine. The stereotactic radiotherapy itself is a targeted treatment, which can be effective at controlling local tumour growth. However, as with any medical treatment, there are potential risks associated with stereotactic radiotherapy, such as side effects from the radiation, which your doctor will discuss with you. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

  • Clinique Claude Bernard
    Verified postcode
    Albi, France· Not yet recruiting
  • Institut de Cancérologie de l'Ouest
    Verified postcode
    Angers, France· Recruiting
  • Institut Bergonié
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • Radiothérapie Bordeaux Nord Aquitaine
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • Centre François Baclesse
    Verified postcode
    Caen, France· Recruiting
  • Centre Jean Perrin
    Verified postcode
    Clermont-Ferrand, France· Not yet recruiting
  • CHU Henri Mondor
    Verified postcode
    Créteil, France· Not yet recruiting
  • Centre Georges François LECLERC
    Verified postcode
    Dijon, France· Not yet recruiting
  • Institut de cancérologie de Bourgogne (Dijon, Auxerre, Chalon sur Saône)
    Verified postcode
    Dijon, France· Recruiting
  • CHD Vendée
    Verified postcode
    La Roche-sur-Yon, France· Not yet recruiting
  • Centre de radiothérapie Guillaume le Conquérant
    Verified postcode
    Le Havre, France· Not yet recruiting
  • Centre Oscar Lambret
    Verified postcode
    Lille, France· Recruiting

Common questions

What does 'oligoprogressive kidney cancer' mean?

It means your kidney cancer is mostly controlled by your current medicine, but a few small spots (1 to 3) have started to grow or appear in a limited number of areas.

What is stereotactic radiotherapy?

It's a very precise type of radiation treatment that delivers a high dose to just the cancer cells, usually in one or a few sessions, while trying to protect healthy tissue.

Why is this study important?

It's trying to find out if treating just the few growing cancer spots with special radiation can help people stay on their current cancer medicine longer, rather than having to switch to a new one sooner.

Will I have to stop my current cancer medicine if I join?

No, the study aims to allow you to continue your current systemic treatment for your kidney cancer while the radiation is given to the growing spots.

What are the main goals of the study?

To see if this targeted radiation can effectively control the small growing cancer spots and help delay the need for different types of cancer medicine later on.

How to find out more

Nazim KALHADI, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Phase II Study Assessing Stereotactic Radiotherapy in Ther…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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