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RecruitingPHASE2INTERVENTIONAL

Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions

This study is exploring a new way to treat pain caused by cancer that has spread to the spine, called spinal metastases. Currently, radiotherapy helps control the cancer and ease pain, but some people still have pain or develop problems with their spine becoming unstable. Vertebroplasty is a procedure that helps strengthen weakened bones in the spine and can quickly reduce pain. Researchers believe that combining these two treatments – radiotherapy and vertebroplasty – might work better together. The study aims to see if this combined approach can ease pain more effectively, keep the spine stable, and improve quality of life for longer, compared to radiotherapy on its own. This isn't a standard treatment yet, and the study will help us understand if it could become one in the future.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
AHS Cancer Control Alberta
Enrolment target
64
Start
03 Mar 2021
Estimated completion
01 Nov 2027

What is this study about?

When cancer spreads to the spine, it's called spinal metastases. This can cause pain and sometimes make the spine weak, leading to further problems. Often, doctors use radiotherapy to treat these areas, which helps to control the cancer and reduce pain. However, for some people, the pain doesn't completely go away, or it returns too quickly. Also, radiotherapy doesn't always prevent the spine from becoming unstable, which can cause more pain.

Another treatment available is vertebroplasty. This is a procedure where special bone cement is injected into weakened spinal bones to strengthen them. It's known to be very good at quickly reducing pain and improving how well a person can move, especially when the spinal bones have fractured. However, vertebroplasty on its own doesn't treat the cancer itself in the same way radiotherapy does.

This study is looking at whether combining radiotherapy with vertebroplasty could be more effective than radiotherapy alone. The idea is that radiotherapy would target the cancer, while vertebroplasty would help stabilise the spine, relieve pain, and potentially prevent future problems. This combined approach isn't a standard treatment yet, and this study aims to find out if it offers real benefits for patients and could become a common treatment option in the future.

Key takeaways

  • This study combines radiotherapy and vertebroplasty for spinal pain.
  • It aims to reduce pain more effectively and stabilise the spine.
  • It's for people with cancer that has spread to their spine.
  • This is a new approach, not a standard treatment yet.
  • Participation involves regular visits and evaluations.
  • You have the right to withdraw from the study at any time.

Who may be eligible?

To be able to take part in this study, you would need to be 18 years old or older. You must have cancer that has spread to your spine (spinal metastases), which has been confirmed by scans like a CT, MRI, or bone scan. The cancer in your spine also needs to be causing you pain, specifically in your upper back or lower back (not your neck).

You should also be well enough to manage daily activities and have a life expectancy of more than six months. It's important that you are able and willing to attend all study visits, follow the treatment plan, and have any necessary tests. If you are a woman who could become pregnant, you would need to have a negative pregnancy test and agree to use effective contraception during the study.

There are also some things that might mean you can't join. For example, if you've already had radiotherapy to the exact part of your spine being studied, or if your overall health isn't considered strong enough for the study treatments.

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. Are you 18 years old or older?
  2. Do you have cancer that has spread to your spine (diagnosed by scans)?
  3. Are you experiencing pain in your upper or lower back due to spinal cancer?
  4. Do you feel well enough to attend regular appointments and follow a treatment plan?
  5. Have you not had radiotherapy to the exact affected spinal level recently?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic for assessments and treatments. This will include having radiotherapy sessions, and potentially a vertebroplasty procedure, depending on which group you are in. You will likely have blood tests, scans (like CT, MRI, or bone scans) to check on your spinal condition, and complete questionnaires to measure your pain levels and how you're feeling overall.

The study will involve several visits over a period of time, with follow-up appointments to track your progress and any effects of the treatment. The total duration of your participation, including follow-up, will be made clear to you by the study team. You'll be asked to follow specific instructions regarding treatment and activities, and it’s important to attend all scheduled appointments.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as receiving a new combined treatment that could be more effective at relieving pain and stabilising your spine than standard treatment. However, as this is a new type of combined treatment, there are also potential risks involved, which could include side effects from the radiotherapy, risks associated with the vertebroplasty procedure, or side effects from any medications. The study team will explain all known risks and discomforts to you in detail before you decide to join. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Cross Cancer Institute
    Verified postcode
    Edmonton, Canada· Recruiting

Common questions

What are spinal metastases?

Spinal metastases are when cancer cells spread from their original location to the bones of your spine.

What is radiotherapy?

Radiotherapy is a treatment that uses high-energy rays to kill cancer cells or stop them from growing.

What is vertebroplasty?

Vertebroplasty is a procedure where special bone cement is injected into a weakened spinal bone to make it stronger and reduce pain.

Will I definitely get the new combined treatment?

This is a study, so participants are usually put into different groups by chance. Some might get the new combined treatment, and others might get the standard treatment.

Will this study cure my cancer?

This study aims to manage pain and stabilise the spine in patients with spinal metastases, but it is not intended to be a cure for cancer.

How to find out more

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 "Trial of Combined Radiotherapy and Vertebroplasty for Patien…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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