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RecruitingPHASE3INTERVENTIONAL

Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery

This research study is looking at the best way to treat a specific type of brain tumour called grade 2 meningioma after surgery. If you've had this tumour completely removed, doctors want to know if having radiation therapy afterwards is better than just keeping a close eye on you (observation). Radiation therapy uses special energy to kill any remaining tumour cells. The study is comparing these two approaches to see which one is more effective at preventing the tumour from coming back and improving long-term health. It also checks for side effects and how treatments affect daily life.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
NRG Oncology
Enrolment target
163
Start
12 Sep 2017
Estimated completion
15 Jun 2027

What is this study about?

You might be reading this because you or someone you know has been diagnosed with a brain tumour called a meningioma. This particular study focuses on 'Grade 2 meningioma,' which means the tumour is a bit more likely to grow back than a less aggressive type, even after it's been completely removed by surgery. Doctors are trying to find the best way to make sure these tumours don't return.

Currently, after surgery, there are two main approaches for Grade 2 meningioma. One is called 'observation,' where doctors regularly check with scans to make sure the tumour hasn't come back. The other is 'radiation therapy,' which uses high-energy rays to kill any tiny tumour cells that might have been left behind, even if they can't be seen. This study is like a comparison, trying to figure out which of these two approaches works better for people who have had their Grade 2 meningioma completely removed.

By comparing observation with radiation therapy, the researchers hope to learn if radiation therapy after surgery helps people stay cancer-free for longer and improves their quality of life. They will also be looking closely at any side effects of the treatments. The results of this study could help doctors worldwide decide on the best follow-up care for future patients with this type of meningioma.

Key takeaways

  • This study compares radiation therapy with observation after surgery for Grade 2 meningioma.
  • It aims to find out which approach is better at preventing the tumour from returning.
  • Participation involves either radiation therapy or regular scans and check-ups.
  • You will be closely monitored for up to 10 years.
  • The study helps improve future care for patients with this type of tumour.

Who may be eligible?

This study is for adults who have recently been diagnosed with a specific type of brain tumour called 'Grade 2 meningioma.' Your tumour must have been completely removed by surgery from inside your head.

An important point is that the surgery to remove the tumour must have happened within the last six months. Doctors will need to confirm from your medical records and scans that the tumour was indeed completely removed. If you had an initial surgery and then needed another one to ensure everything was removed, that's okay, as long as the last surgery was also within the six-month timeframe.

Your age must be 18 years or older, and the study is open to both men and women. If you're unsure if you meet these requirements, it's always best to discuss it with your doctor.

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. Have I been diagnosed with a Grade 2 meningioma?
  2. Was my tumour completely removed by surgery?
  3. Did my surgery happen within the last 6 months?
  4. Am I 18 years old or older?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be randomly assigned to one of two groups, like flipping a coin. You won't get to choose which group you're in. One group will be 'observation,' meaning doctors will regularly monitor you with scans. The other group will receive radiation therapy, which involves daily treatments, usually five days a week, for about six to seven weeks. Throughout the study, both groups will have regular MRI brain scans and blood tests.

After your main treatment (either observation or radiation therapy) is complete, you'll have follow-up appointments. These will be quite frequent at first (at 3, 6, and 12 months), then every six months for the next two years, and finally once a year for up to 10 years. During these follow-ups, doctors will check how you're doing, look for any signs of the tumour returning, and ask about your quality of life. You'll also have the right to withdraw from the study at any time.

Potential risks and benefits

Participating in this study might offer you some benefits, such as very close monitoring of your health and access to potential treatments that might be more effective. However, there's no guarantee of direct personal benefit, and the goal is to find better treatments for future patients. Potential risks include side effects from radiation therapy, such as tiredness or skin changes, or the chance that the tumour could return if you're in the observation group. You will be closely monitored for any issues, and you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (214)

  • University of Alabama at Birmingham Cancer Center
    Verified postcode
    Birmingham, United States· Active not recruiting
  • Saint Joseph's Hospital and Medical Center
    Verified postcode
    Phoenix, United States· Recruiting
  • Mayo Clinic Hospital in Arizona
    Verified postcode
    Phoenix, United States· Active not recruiting
  • Mayo Clinic in Arizona
    Verified postcode
    Scottsdale, United States· Active not recruiting
  • University of Arizona Cancer Center-Orange Grove Campus
    Verified postcode
    Tucson, United States· Suspended
  • Banner University Medical Center - Tucson
    Verified postcode
    Tucson, United States· Suspended
  • University of Arizona Cancer Center-North Campus
    Verified postcode
    Tucson, United States· Suspended
  • Kaiser Permanente-Anaheim
    Verified postcode
    Anaheim, United States· Recruiting
  • Sutter Cancer Centers Radiation Oncology Services-Auburn
    Verified postcode
    Auburn, United States· Recruiting
  • Kaiser Permanente-Bellflower
    Verified postcode
    Bellflower, United States· Recruiting
  • Kaiser Permanente Dublin
    Verified postcode
    Dublin, United States· Recruiting
  • Kaiser Permanente Los Angeles Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting

Common questions

What is a Grade 2 meningioma?

It's a type of brain tumour that starts in the protective layers around the brain and spinal cord. Grade 2 means it's a bit more likely to grow back after surgery than a less aggressive type.

What does 'completely removed by surgery' mean?

It means the surgeons believe they've taken out all visible parts of the tumour. This is confirmed by looking at the removed tissue and special scans.

What is radiation therapy?

It's a treatment that uses high-energy rays, like X-rays, to target and destroy any cancer cells that might have been left behind after surgery.

What does 'observation' involve?

Observation means your doctors will regularly monitor you with scans and check-ups to make sure the tumour hasn't returned, rather than giving you immediate additional treatment.

How long will I be in the study?

After your initial treatment (observation or radiation), you'll have follow-up checks for up to 10 years.

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 "Observation or Radiation Therapy in Treating Patients With N…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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