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RecruitingPHASE3INTERVENTIONAL

Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases

This study is looking at pain relief for people whose cancer has spread to their bones, specifically areas outside the spine. We're comparing two ways of giving radiation treatment. One is standard radiotherapy, which is a common way to treat cancer pain. The other is a newer, more targeted treatment called Stereotactic Body Radiotherapy (SBRT). SBRT delivers a high dose of radiation very precisely to the painful area, trying to avoid healthy tissues nearby. The main goal is to find out if SBRT works better than standard treatment in easing pain. We're also checking how long the pain relief lasts and if the cancer grows less after each treatment.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Canadian Cancer Trials Group
Enrolment target
230
Start
07 Mar 2025
Estimated completion
01 Jan 2028

What is this study about?

When cancer spreads from its original site to the bones, it can cause pain. This study is exploring different ways to help manage that pain using radiation treatment. We're particularly interested in bones outside of the spine, like those in the arms or legs.

There are two main types of radiation therapy being compared in this study. The first is called 'standard conventional radiotherapy'. This is a common and established treatment that aims to reduce pain by delivering radiation to the affected bone area. The second is a more advanced treatment called 'Stereotactic Body Radiotherapy' or SBRT. SBRT is like a highly targeted missile; it gives a very strong dose of radiation to the exact painful spot while trying to protect the healthy tissues around it from unnecessary radiation.

The main reason for this study is to see if SBRT is more effective at relieving pain than standard radiotherapy. We also want to understand if it offers longer-lasting pain relief or helps control the cancer in the bone better. By comparing these two treatments, doctors hope to find the best way to help people who are experiencing pain from cancer that has spread to their bones.

Key takeaways

  • Compares standard vs. new radiation for bone pain (not spine).
  • Aims for better, more targeted pain relief.
  • Participation involves 5 radiation sessions and 6 months of follow-up.
  • You won't choose your treatment; it's assigned randomly.
  • Could help improve future care for similar cancer pain.

Who may be eligible?

To join this study, you need to have a confirmed cancer diagnosis and pain in a bone caused by cancer that has spread. This pain must be outside your spine (so not in your back or neck). Your doctors should also believe you're likely to live for more than six months.

You can't join if the cancer pain is in your hands, feet, head, or spine. Also, if you've already had radiation therapy to the exact painful spot being studied, or if you've had certain types of chemotherapy recently, you might not be able to take part. This study isn't for people with very specific types of cancer like small cell or germ cell cancer. Pregnant or breastfeeding women cannot participate, nor can those with unstable bone fractures that would need surgery.

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 cancer that has spread to my bones?
  2. Is my bone pain outside of my spine (not in my back or neck)?
  3. Have I not had radiation to this exact painful spot before?
  4. Am I generally well enough to undergo treatment, with my doctor expecting me to live more than 6 months?
  5. Am I not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either standard radiotherapy or the more focused SBRT. You won't get to choose which treatment you receive. Both treatments involve 5 sessions of radiation. After your treatment, the study team will check in with you at 3 months and again at 6 months to see how your pain is, how you're feeling, and to monitor the cancer in the bone. This follow-up will involve checking your pain levels and possibly having scans.

Potential risks and benefits

Taking part in this study could potentially lead to better pain relief from your bone metastases, especially if the newer SBRT treatment proves more effective. Both types of radiation therapy have potential side effects, which your doctor will explain in detail. These can vary depending on the area being treated. You might experience tiredness or skin changes. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual care.

Locations (9)

  • BCCA - Vancouver
    Verified postcode
    Vancouver, Canada· Recruiting
  • Juravinski Cancer Centre at Hamilton Health Sciences
    Verified postcode
    Hamilton, Canada· Not yet recruiting
  • Kingston Health Sciences Centre
    Verified postcode
    Kingston, Canada· Recruiting
  • London Health Sciences Centre Research Inc.
    Verified postcode
    London, Canada· Recruiting
  • Stronach Regional Health Centre at Southlake
    Verified postcode
    Newmarket, Canada· Recruiting
  • Odette Cancer Centre
    Verified postcode
    Toronto, Canada· Recruiting
  • University Health Network
    Verified postcode
    Toronto, Canada· Recruiting
  • CHUM-Centre Hospitalier de l'Universite de Montreal
    Verified postcode
    Montreal, Canada· Recruiting
  • Hotel-Dieu de Quebec
    Verified postcode
    Québec, Canada· Recruiting

Common questions

What kind of cancer is this study for?

This study is for people whose cancer has spread to their bones (metastatic cancer), specifically outside of the spine.

What is the difference between the two treatments?

Both are radiation treatments. Standard radiotherapy spreads radiation over a slightly wider area, while SBRT is much more focused, delivering a high dose precisely to the painful spot.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to one of the two treatment groups, like flipping a coin, to ensure a fair comparison.

How long will I be followed in the study?

After your radiation treatment, you will have follow-up appointments at 3 months and 6 months to check your pain and how the cancer is doing.

What information will the doctors collect?

They will mainly look at how your pain changes after treatment and use scans to see if the cancer in the bone progresses.

How to find out more

Wendy Parulekar

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 vs Conventional Palliative Ra…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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