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RecruitingNAINTERVENTIONAL

Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)

This study, called OligoRARE, is for people with rare cancers that have spread to a few places in the body, but not widely. It's looking to see if adding a special type of radiation called Stereotactic Body Radiotherapy (SBRT) to their usual cancer treatment helps them live longer. Researchers are comparing two groups: one receiving their standard treatment, and another receiving standard treatment plus SBRT to all areas where the cancer has spread. This is a big study taking place in different centres, and the aim is to find out if SBRT can improve outcomes for people with these specific types of rare cancers.

At a glance

Status
Recruiting
Phase
NA
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Enrolment target
200
Start
10 Jun 2021
Estimated completion
01 Feb 2030

What is this study about?

Imagine you have a rare type of cancer that has spread to small, limited areas of your body. Doctors call this 'oligometastatic' cancer. This study, called OligoRARE, is designed to investigate a new approach to treating these specific situations. It wants to see if a special and very precise type of radiation, called Stereotactic Body Radiotherapy (SBRT), can improve your chances of living longer when added to the usual treatment you would receive.

SBRT is a highly focused type of radiation that delivers a strong dose of radiation to the cancer cells while trying to spare the healthy tissues around them. The study is comparing two ways of treating people: some will get the standard care that their doctors would usually recommend, and others will get that same standard care PLUS the SBRT treatment aimed at all the places where the cancer has spread. Researchers will then look at which group lives longer and has better results.

This is a 'Phase III' study, which means it's a large trial designed to confirm if a new treatment is better than existing ones. The hope is that by adding this precise radiation, people with these rare, limited spread cancers might have a better outcome than with standard treatment alone.

Key takeaways

  • Tests a new radiation treatment (SBRT) for rare cancers that have spread a little.
  • Compares SBRT plus usual care to usual care alone.
  • Aims to see if SBRT helps people live longer.
  • Involves being randomly assigned to one of two treatment groups.
  • Focused on specific rare cancers, not common ones like breast or prostate cancer.
  • You can stop participating at any time.

Who may be eligible?

To join this study, your doctor will need to check some things. You must have a rare type of cancer that has spread to between one and five different places in your body. Your main cancer site should be under control, meaning it was treated at least three months ago and hasn't grown since. Importantly, the doctors need to be confident that all these cancer spots can be safely treated with radiation.

You should also be generally well, able to do most daily activities, and doctors expect you to live for at least six more months. You need to be 18 years or older to take part. Also, your body should be able to handle radiation treatment without serious problems, especially if your cancer has spread to your liver or involves your bowel.

There are also some reasons why you might not be able to join. For example, if your primary cancer started in the prostate, breast, lung, or colon, this study isn't for you. Also, if you have certain other serious health issues like severe lung disease, or conditions affecting your gut or connective tissues, you might not be eligible. If the cancer has only spread to your brain, or if you have fluid build-up around your lungs or in your belly from the cancer, or if the cancer spots are larger than 6 cm, you won't be able to join. Your doctor will carefully review all these details with you.

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 a rare cancer type (not breast, prostate, lung, or colon)?
  2. Has my cancer spread to between 1 and 5 spots in my body?
  3. Is my main tumour under control and not actively growing?
  4. Am I generally well and able to do most daily activities?
  5. Am I 18 years old or older?
  6. Have I discussed with my doctor if my cancer spots can be safely treated with radiation?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin for fairness. One group will receive the standard care treatment that your doctors would normally recommend for your type of cancer. The other group will receive that same standard care PLUS the special Stereotactic Body Radiotherapy (SBRT) to all the areas where your cancer has spread.

The SBRT treatment involves a few visits for precise radiation sessions. Both groups will have regular check-ups and scans to monitor their health and how the treatment is working. The study will track your progress over time to see how long you live and how well you respond to treatment. The exact number of visits and tests will depend on your specific situation and the treatment plan, but the study continues to monitor your health and cancer status for a long time after the initial treatment.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A possible benefit of joining this study is that adding SBRT to your standard treatment might help you live longer compared to standard treatment alone. Your doctors and the research team will carefully monitor you for any side effects from the treatments. As with any radiation treatment, SBRT can have side effects, and these will depend on where the radiation is aimed. These will be fully explained to you before you agree to participate. You will also have access to standard care, which is a known and established treatment for your condition. It’s very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Institut Jules Bordet
    Verified postcode
    Anderlecht, Belgium· Recruiting
  • Universitair Ziekenhuis Gent
    Verified postcode
    Ghent, Belgium· Recruiting
  • Gasthuiszusters Antwerpen - Sint-Augustinus
    Verified postcode
    Wilrijk, Belgium· Recruiting
  • Centre Oscar Lambret
    Verified postcode
    Lille, France· Recruiting
  • Gustave Roussy
    Verified postcode
    Villejuif, France· Recruiting
  • Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
    Verified postcode
    Hamburg, Germany· Recruiting
  • Istituto Europeo di Oncologia
    Verified postcode
    Milan, Italy· Recruiting
  • Medical University Of Gdansk
    Verified postcode
    Gdansk, Poland· Recruiting
  • Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
    Verified postcode
    Warsaw, Poland· Recruiting
  • Inselspital
    Verified postcode
    Bern, Switzerland· Recruiting
  • UniversitaetsSpital Zurich
    Verified postcode
    Zurich, Switzerland· Recruiting
  • University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre
    Verified postcode
    Birmingham, United Kingdom· Recruiting

Common questions

What does 'rare oligometastatic cancer' mean?

It means you have a type of cancer that isn't common, and it has spread to a small, limited number of places in your body, usually 1 to 5 spots.

What is SBRT?

SBRT is a powerful, very precise type of radiation treatment that aims high doses of radiation directly at cancer spots, trying to avoid healthy tissue.

Will I definitely get SBRT if I join this study?

No, you will be randomly put into one of two groups: one gets standard treatment only, and the other gets standard treatment plus SBRT. It's like drawing lots.

How long will I be in the study?

The study will follow your health and cancer progress over a long period to see the full effects of the treatments.

What if I change my mind about participating?

You can leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

EORTC HQ

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 "Stereotactic Body Radiotherapy in Patients With Rare Oligome…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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