RecruitingNAINTERVENTIONAL

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

The PRIMALung study is investigating the best way to manage small cell lung cancer to prevent it from spreading to the brain. Currently, some patients receive preventative brain radiation therapy (called PCI) along with regular MRI scans of the brain. This study wants to find out if having regular brain MRI scans alone is just as effective as the combination treatment. They are particularly interested in whether avoiding radiation therapy can lead to a better quality of life and preserve brain function, while still keeping the cancer under control. The study will compare how long people live and their brain health in both groups, as well as looking at any side effects and overall well-being. It aims to help doctors decide on the best treatment approach for patients with this type of lung cancer.

At a glance

Status

Recruiting

Phase

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

600

Start

27 Oct 2022

Estimated completion

01 Apr 2028

Limited Stage Small Cell Lung Cancer Extensive-stage Small-cell Lung Cancer

What is this study about?

When someone has small cell lung cancer, there's a risk that the cancer cells could spread to the brain. To try and stop this, some patients are offered a treatment called prophylactic cranial irradiation (PCI), which is a type of radiation therapy to the head. This is usually given alongside regular brain scans (MRIs) to check for any changes. However, PCI can sometimes have side effects that affect brain function and overall well-being.

This study, called PRIMALung, wants to explore if we can achieve similar good results by only using regular brain MRI scans and avoiding the radiation therapy altogether. The main goal is to see if skipping the radiation therapy is just as good for preventing the cancer from spreading to the brain and for how long patients live overall. They're also very keen to understand if avoiding radiation can improve a patient's quality of life and reduce the risk of problems with memory or thinking skills.

Researchers will carefully compare two groups of patients. One group will continue with the current approach (radiation therapy plus scans), and the other group will only have the regular brain scans. By doing this, they hope to gather important information that will help doctors make better decisions about treatment for future patients with small cell lung cancer, aiming to minimise side effects while still providing effective care.

Key takeaways

This study compares two ways to prevent brain spread in small cell lung cancer.
It aims to see if regular brain scans alone are as good as scans plus preventative radiation.
Researchers will check how long people live and their brain health.
The goal is to improve quality of life and minimise treatment side effects.
It could help doctors decide the best future care for patients.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with small cell lung cancer. This includes both those with limited-stage cancer (meaning it's found in one area and hasn't spread widely) and extensive-stage cancer (meaning it has spread to other parts of the body).

To join, you must have already finished your standard treatment for lung cancer, which usually includes chemotherapy. Some patients might also have had radiation therapy to the chest or surgery. It's important that your cancer is currently stable and hasn't grown after your initial treatment, and that you don't have any cancer spread to the brain or surrounding tissues when they check before you start the study.

You also need to be generally well enough to take part, meaning you can carry out most of your daily activities without too much difficulty. There are specific checks on your kidney function to ensure it's healthy enough for the study. If you meet these main criteria, your doctors can look at the full details to see if this study would be a good fit for you.

Quick self-check

I am 18 years old or older.
I have been diagnosed with small cell lung cancer.
I have finished my main cancer treatments (like chemotherapy).
My cancer is currently stable and hasn't spread to my brain.
I am generally well and can do most daily activities.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would be randomly assigned to one of two groups. One group will continue with regular brain scans (MRI) as well as receiving a preventative dose of radiation therapy to the brain (PCI). The other group will only have regular brain MRI scans, without the radiation therapy.

Both groups will have ongoing follow-up appointments and regular brain MRI scans to monitor your health and check for any signs of cancer spread. The study will also include questionnaires to understand your overall health, well-being, and any changes in your thinking or memory. The exact number of visits and the total duration aren't detailed here but will be clearly explained by the study team. You won't be given any new experimental medication as part of this study.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is helping to determine if preventative brain radiation can be safely avoided, which might reduce potential side effects like fatigue or changes in thinking. You might also benefit from very close monitoring of your health. However, there's a chance that avoiding radiation therapy might not be as effective in preventing cancer spread to the brain for some individuals. The study aims to understand these trade-offs more clearly. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (41)

Medical University of Graz - Radio-oncology
Graz, Austria· Recruiting
Institut Jules Bordet
Anderlecht, Belgium· Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Belgium· Recruiting
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk, Belgium· Recruiting
C.H.U. Sart-Tilman
Liège, Belgium· Recruiting
Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus
Wilrijk, Belgium· Recruiting
Institut Sainte Catherine (UNICANCER)
Avignon, France· Recruiting
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (UNICANCER)
Bayonne, France· Recruiting
Institut Bergonie (UNICANCER)
Bordeaux, France· Recruiting
Centre Francois Baclesse (CLCC) (UNICANCER)
Caen, France· Recruiting
CHU de Dijon - Centre Georges-Francois-Leclerc (UNICANCER)
Dijon, France· Recruiting
Centre Hospitalier Departemental Vendee (UNICANCER)
La Roche-sur-Yon, France· Recruiting

+29 more sites — see the official record for the full list.

Common questions

What is small cell lung cancer?

Small cell lung cancer is a type of lung cancer that can grow quickly. Doctors use different treatments to manage it and stop it from spreading.

What is 'preventative brain radiation'?

This is a type of radiation treatment given to the brain to try and stop small cell lung cancer cells from spreading there, even if no cancer is seen in the brain yet.

What is a brain MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of the inside of your head, which helps doctors check for any changes or problems.

Why is this study important?

This study is important because it wants to find out if people with small cell lung cancer can avoid preventative brain radiation, which can have side effects, while still getting the best possible care and health outcomes.

Will I still get my usual cancer treatment if I join?

Yes, you must have completed your standard cancer treatment before joining this study. The study focuses on how to best monitor and prevent brain spread after that initial treatment.

How to find out more

EORTC Reception

eortc@eortc.org +3227741611 Official trial record

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