RecruitingNAINTERVENTIONAL

Trial of Preoperative Radiosurgery Versus Postoperative Stereotactic Radiotherapy for Resectable Brain Metastases

This study is looking at two different ways to treat brain tumours, called brain metastases, which have spread from cancer elsewhere in the body. Typically, these tumours are removed by surgery, and then radiation is given afterwards to help stop the cancer from returning. This trial wants to see if giving a single dose of radiation before surgery is better than giving several doses after surgery. Specifically, it's checking if radiation before surgery can help prevent the cancer cells from spreading to the delicate membranes surrounding the brain (called leptomeningeal disease) in the 12 months after the operation. By doing this, researchers hope to find a more effective way to prevent the cancer from coming back in this area.

At a glance

Status

Recruiting

Phase

Sponsor

Susanne Rogers

Enrolment target

200

Start

29 Jul 2022

Estimated completion

30 Dec 2028

Brain Metastases, Adult

What is this study about?

When cancer spreads from another part of the body to the brain, these new growths are called brain metastases. If these tumours can be safely removed, surgery is often an important treatment step. After surgery, it's common to have radiation therapy to help kill any remaining cancer cells and reduce the chance of the tumour growing back.

Traditionally, radiation therapy is given after surgery, often in several small doses. However, doctors have noticed that even with this treatment, some aggressive cancer cells can still spread to the delicate coverings of the brain and spinal cord, a problem known as leptomeningeal disease (LMD). This trial is exploring a different approach: giving a single, focused dose of radiation therapy before the surgery takes place.

The idea behind giving radiation before surgery is that it might be more effective at targeting the tumour when it's still clearly visible. It could also kill any cancer cells that might otherwise spread during the surgery itself. The study aims to compare this single dose of pre-surgery radiation with the standard approach of several doses after surgery, to see which method is better at preventing LMD and improving overall outcomes for patients.

Key takeaways

Compares radiation before surgery versus after surgery for brain tumours.
Aims to prevent cancer spreading to the brain's lining (LMD).
Participation involves random assignment to one of two treatment groups.
Regular check-ups and scans will be part of the study.
You can leave the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you would generally need to be at least 18 years old and have a good general level of health, meaning you can carry out most of your daily activities without much difficulty. You must have been diagnosed with cancer that has spread to your brain, and your doctors must have decided that surgery to remove your brain tumour is the right treatment for you. The brain tumour should be no larger than 4 centimetres across.

There are also some important things that would prevent you from taking part. For example, if you have certain types of cancer that respond very well to radiation (like lymphoma), or if your brain tumour is causing severe pressure in your head and needs urgent surgery, you wouldn't be able to join. You also can't have already had radiation to your brain for this particular tumour, or have signs that the cancer has already spread to the coverings of your brain.

Before you can join, the study team will carry out several checks, including blood tests and scans, to make sure it's safe and appropriate for you to take part. Women who are pregnant or breastfeeding, or who are of childbearing age and not willing to use effective contraception, would also not be able to participate.

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?
Do you have a brain tumour that your doctors plan to remove with surgery?
Is your brain tumour no bigger than 4 centimetres?
Have you NOT had previous radiation to this specific brain tumour?
Are you able to have MRI scans?

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 treatment groups – like flipping a coin, neither you nor your doctor can choose. One group will have a single radiation treatment before their brain surgery, and the other group will have 5 radiation treatments after their brain surgery. All participants will undergo brain surgery as planned.

After your treatment, you will have regular check-ups, including MRI scans, to monitor your recovery and the tumour. The study team will explain the schedule for these visits and assessments in detail. The total duration of the study would involve monitoring your progress for at least 12 months after your surgery. There are no extra medications provided by the study, but your doctors will manage any necessary steroids as part of your usual care.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive a high standard of care and contribute to medical knowledge that could help future patients. You might receive a treatment that proves to be more effective than standard care. However, there are also potential risks, including side effects from the radiation therapy or surgery, which will be carefully explained to you. Since treatments are assigned by chance, you might not receive the new approach being tested. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Tirol Kliniken Innsbruck
Verified postcode
Innsbruck, Austria· Active not recruiting
Knappschaft Kliniken, Universitätsklinikum Bochum GmbH
Verified postcode
Bochum, Germany· Recruiting
UKGM-Giessen
Verified postcode
Giessen, Germany· Recruiting
Universitätsklinikum Schleswig Holstein
Verified postcode
Kiel, Germany· Recruiting
Kantonsspital Aarau
Verified postcode
Aarau, Switzerland· Recruiting
Inselspital, Universitätsklinik für Radio-Onkologie
Verified postcode
Bern, Switzerland· Recruiting
Kantonsspital Graubünden
Verified postcode
Chur, Switzerland· Recruiting
Luzerner Kantonsspital
Verified postcode
Lucerne, Switzerland· Recruiting
Kantonsspital St. Gallen
Verified postcode
Sankt Gallen, Switzerland· Recruiting
Kantonsspital Winterthur
Verified postcode
Winterthur, Switzerland· Recruiting

Common questions

What is a brain metastasis?

A brain metastasis is a tumour in the brain that has spread from another type of cancer elsewhere in your body.

What is radiosurgery?

Radiosurgery is a very precise type of radiation therapy that delivers a high dose of radiation in one or a few treatments, targeting the tumour while sparing healthy brain tissue.

What is leptomeningeal disease (LMD)?

LMD is when cancer cells spread to the delicate membranes and fluid surrounding your brain and spinal cord. We want to prevent this.

Why can't I choose which treatment I get?

Treatments are chosen randomly, like drawing lots, to ensure the results are fair and unbiased. This helps doctors learn which method is truly more effective.

Will my regular doctors still look after me?

Yes, your regular medical team will continue to manage your overall care throughout the study.

How to find out more

Susanne Rogers, MD PhD

susanne.rogers@ksa.ch +41 62 838 57 26 Official trial record

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