RecruitingNAINTERVENTIONAL

Preoperative Stereotactic Radiotherapy for Treatment of Spinal Metastases

This clinical trial is investigating a new approach for people who need surgery for spinal tumours that have spread from other cancers. It involves giving a special type of focused radiation therapy, called Stereotactic Body Radiotherapy (SBRT), shortly before the surgical operation. The main goals are to find out if this radiation helps to control the tumour in the spine and how it affects patients' pain, their ability to carry out daily activities, and their overall quality of life after surgery. Participants will have scans and fill in questionnaires before and after their treatment to help the researchers understand the effects.

At a glance

Status

Recruiting

Phase

Sponsor

University Medical Center Goettingen

Enrolment target

Start

01 Aug 2025

Estimated completion

01 Jan 2027

Spinal Metastases Solid Tumor Cancer

What is this study about?

This study is looking into a treatment for people who have cancer that has spread to their spine, creating what are called spinal metastases. When these tumours press on nerves or make the spine unstable, surgery might be needed. This trial aims to see if giving a special, precise type of radiation therapy, called Stereotactic Body Radiotherapy (SBRT), a short time before surgery can make a difference. SBRT delivers high doses of radiation to the tumour very accurately, aiming to damage the cancer cells while protecting healthy tissue as much as possible.

The main questions the researchers want to answer are whether this pre-surgery radiation helps to keep the tumour under control in the treated part of the spine. They will check this using MRI and CT scans a few months after surgery. They also want to understand how this treatment affects patients' lives. This includes looking at changes in pain levels, how well people can do their usual daily activities, and their general quality of life after the treatment.

By carefully studying these things, the researchers hope to find better ways to treat spinal metastases. This could potentially help patients manage their condition more effectively and improve their comfort and daily living after surgery.

Key takeaways

This study is for adults needing surgery for spinal tumours that spread from other cancers.
It combines special radiation (SBRT) before surgery.
Researchers want to see if SBRT helps control tumours and improves pain/daily life.
Participation involves extra scans and questionnaires over 6 months.
You can leave the study at any time without affecting your care.

Who may be eligible?

To join this study, you generally need to be an adult, aged 18 or over, who is already planned to have surgery for a spinal tumour that has spread from another cancer. Doctors will also need to believe you are likely to live for at least another six months.

It’s important that you understand what the study involves and can agree to take part after having all your questions answered. This ensures you're making an informed decision about participating.

However, some people won't be able to join. For example, if your tumour is causing severe nerve problems or issues with bladder or bowel control that need emergency surgery, this study might not be suitable. Also, if the tumour's size or location means the specific type of radiation used in this study isn't appropriate, you wouldn't be able to take part.

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.

Are you 18 years old or older?
Are you scheduled for spinal surgery because cancer has spread to your spine?
Do your doctors expect you to live for at least another 6 months?
Do you understand what the study involves and feel able to give your consent to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive a special type of focused radiation therapy (SBRT) to your spinal tumour shortly before your planned surgery. Before your surgery, and again at 3 and 6 months afterwards, you will have MRI and CT scans to check the tumour's size. You will also be asked to fill in several questionnaires. These will ask about your pain levels over the last 24 hours, your ability to do daily activities, any back pain, and your general quality of life. There isn't a stated total duration for your involvement, but the follow-up scans and questionnaires are scheduled for 6 months after your surgery.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of better tumour control in your spine compared to surgery alone. While we hope this approach might also improve pain, function, and quality of life, this is what the study is trying to find out. As with any medical treatment, there are potential risks associated with both radiation therapy and surgery, which your doctors will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Medical Center Goettingen
Verified postcode
Göttingen, Germany· Recruiting

Common questions

What is SBRT?

SBRT stands for Stereotactic Body Radiotherapy. It's a very precise way of giving high doses of radiation to a tumour while trying to protect nearby healthy tissues.

What are spinal metastases?

These are tumours in the spine that have spread from a cancer in another part of the body.

Will I still have surgery if I join this study?

Yes, this study involves providing SBRT shortly before your planned spinal surgery.

How long will I be involved in the study?

You'll have assessments, including scans and questionnaires, before surgery and then at 3 and 6 months after your surgery.

Can I stop being part of the study anytime?

Yes, you have the right to withdraw from the study at any point, and this will not affect your future medical care.

How to find out more

Carla Marie Zwerenz, Dr. med.

carlamarie.zwerenz@med.uni-goettingen.de +49 551 39 64501 Official trial record

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