Active not recruitingNAINTERVENTIONAL

Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases

This research is looking into the best way to use radiotherapy with surgery for brain metastases. These are cancers that have spread to the brain and can seriously affect a person's life. While combining surgery and radiotherapy is standard, doctors aren't sure which timing of radiotherapy is best. This study directly compares three approaches: giving radiotherapy before surgery (neoadjuvant), during surgery (intraoperative), or after surgery (adjuvant). By studying tissue, spinal fluid, and blood samples, researchers aim to understand how each method affects the cancer, the body's immune system, and any potential side effects. The goal is to improve treatment and quality of life for patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital Heidelberg

Enrolment target

Start

01 Feb 2024

Estimated completion

01 May 2029

Brain Metastases Radiotherapy

What is this study about?

When cancer spreads to the brain, it's called a brain metastasis. These can be very serious and affect how long someone lives and their quality of life. For some people, doctors can remove these growths with surgery. This study is about finding the best way to combine surgery with another important treatment called radiotherapy (also known as radiation therapy).

Radiotherapy uses high-energy rays to kill cancer cells or stop them from growing. Doctors usually use radiotherapy alongside surgery for brain metastases, but they aren't sure if it's better to give the radiation before surgery, during the surgery itself, or after surgery. This research will compare these three different timings directly: radiotherapy before surgery, during surgery, or after surgery. This is a crucial step to figure out which approach is most effective and safest for patients.

The researchers will closely examine samples taken during surgery, like the removed cancer tissue, as well as blood and spinal fluid. By looking at these samples, they can understand how each type of radiotherapy affects the cancer cells, the body's immune system, and any changes at a microscopic level. They'll also carefully track how well each treatment works (efficacy) and what side effects patients might experience (toxicity). The hope is that this study will lead to better treatment plans for people with brain metastases.

Key takeaways

This study compares three timings for radiotherapy (before, during, or after surgery) for brain metastases.
It aims to find the most effective and safest way to combine radiotherapy with surgery.
Researchers will study samples to understand treatment effects on cancer and the immune system.
Participation involves being randomly assigned to a treatment group and having regular check-ups.
The study includes detailed monitoring for efficacy and side effects.
It could lead to better future treatments for brain metastases.

Who may be eligible?

To join this study, people generally need to be 18 years or older and have certain kinds of cancer that have spread to the brain (brain metastases). They must have 1 to 10 brain metastases, with at least one that can be safely removed by surgery in an area of the brain that's not crucial for things like movement or speech. The brain tumour planned for surgery shouldn't be larger than 5cm. Patients also need to be well enough to have both surgery and stereotactic radiotherapy.

There are also some reasons why someone couldn't join. For example, if a brain tumour needs to be removed immediately because it's causing life-threatening symptoms, or if it's too close to important parts of the brain like the optic nerves or brain stem. People who have had radiotherapy to their brain before, or those with certain types of cancer (like small-cell lung cancer) or other specific medical conditions, would also not be able to take part. Pregnant or breastfeeding women cannot join, nor can those who are already in another similar study.

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 or older?
Do you have cancer that has spread to your brain (1-10 tumours)?
Is at least one of these brain tumours able to be removed by surgery in a safe location?
Is the brain tumour planned for surgery less than 5cm?
Are you well enough for both surgery and radiotherapy?
Have you NOT had brain radiotherapy before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of three groups. This means a computer would decide whether you receive radiotherapy before your surgery, during your surgery, or after your surgery. There are specific timings for when the radiotherapy would be given in relation to your operation. Throughout the study, doctors would collect detailed information, including tissue samples from your surgery, as well as blood and spinal fluid samples. You would also have regular check-ups and imaging scans to see how you are responding to treatment and to monitor for any side effects. The total duration of your participation would depend on your treatment plan and follow-up schedule.

Potential risks and benefits

Potential benefits of taking part in this study include receiving advanced treatment and closely monitored care, which could lead to a better understanding and potentially improved outcomes for your specific condition. You would also contribute to medical knowledge that could help future patients. However, there are potential risks, including side effects from the radiotherapy or surgery, which will be discussed in detail by the study team. As with any clinical trial, there's no guarantee that the treatment will be effective for you personally. It's important to remember that you can withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Department of Radiotherapy, University of Heidelberg
Verified postcode
Heidelberg, Germany

Common questions

What are brain metastases?

Brain metastases are when cancer cells from another part of the body spread to the brain.

What is radiotherapy?

Radiotherapy uses high-energy rays to kill cancer cells and is a common cancer treatment.

What does 'neoadjuvant' or 'adjuvant' mean?

'Neoadjuvant' means treatment given before surgery, and 'adjuvant' means treatment given after surgery.

Will I get to choose which treatment I receive?

No, if you join the study, a computer will randomly assign you to one of the three treatment groups.

What if I change my mind during the study?

You are free to leave the study at any time, and this will not affect your usual medical care.