All studies
Active not recruitingPHASE3INTERVENTIONAL

Single Fraction Stereotactic Radiosurgery Compared With Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease

This research is looking at two different ways of giving radiation therapy to people who have had surgery for cancer that has spread to their brain. Doctors want to find out if giving the radiation in several smaller doses over time (called fractionated stereotactic radiosurgery) is better or worse than giving it all in one large dose (single fraction stereotactic radiosurgery). The main goal is to see which method is better at stopping the cancer from growing back where it was removed. Researchers also want to understand if one approach leads to a better quality of life and fewer side effects for patients. This is a "Phase 3" study, meaning it's comparing a new approach against a standard treatment to see which is more effective and safer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Alliance for Clinical Trials in Oncology
Enrolment target
242
Start
19 Nov 2019
Estimated completion
01 Sep 2028

What is this study about?

This study is for people who have been diagnosed with cancer that has spread to their brain from another part of their body, and they've had surgery to remove the brain tumour. The main point of this research is to compare two common ways of giving focused radiation treatment after surgery. Think of radiation therapy as using very targeted X-rays to destroy any remaining cancer cells.

One method is called 'single dose stereotactic radiosurgery'. This means you receive one powerful blast of radiation directly to the area where the tumour was removed. The other method is 'fractionated stereotactic radiosurgery', which involves receiving several smaller doses of radiation over a few days or weeks to the same area. Doctors want to understand if one of these methods is better at stopping the cancer from returning to the original surgery site. They are also very interested in how these treatments affect a person's overall well-being and daily life.

By taking part, you would be helping doctors learn which radiation approach is most effective and has the fewest side effects, potentially improving care for future patients. It's important to remember that you would be assigned to one of the treatment groups by chance, like flipping a coin. This helps ensure the results are fair and reliable. The study will look closely at how you feel emotionally and physically, as well as tracking any side effects.

Key takeaways

  • Compares two radiation methods after brain tumour removal for cancer that has spread.
  • Aims to find which radiation method is better at preventing cancer return and improving life quality.
  • Participants will be randomly assigned to receive either a single high dose or multiple small doses of radiation.
  • Involves regular check-ups, scans, and questionnaires about well-being.
  • This is a Phase 3 study, comparing a new approach against a standard treatment.
  • Your participation helps improve care for future patients.

Who may be eligible?

To join this study, you must have had surgery within the last 30 days to remove a brain tumour that started elsewhere in your body. The tumour you had removed must have been at least 2cm in size before surgery, and the surgery should have completely removed it.

You can’t have had more than one brain tumour removed. If you have other small brain tumours that weren't removed, you might still be able to join, as long as there are three or fewer of them and they are smaller than 4cm. These remaining small tumours would also be treated with radiation in this study.

Also, your general health and how well you can do daily activities will be assessed (this is called your 'Karnofsky performance status', and it needs to be 60 or higher). If you are a woman who could become pregnant, you'll need a negative pregnancy test, and both men and women must agree to use effective contraception during the study and for a few months after.

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 you recently had surgery to remove a brain tumour that started elsewhere in your body?
  2. Was your brain tumour entirely removed, and was it 2cm or larger before surgery?
  3. Do you have good general health, and can you carry out most daily activities?
  4. If you have other small brain tumours, do you have three or fewer, and are they less than 4cm?
  5. Are you willing to use contraception during the study if applicable?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups. This means you'll either receive the single, high dose of radiation therapy, or multiple, smaller doses given over time. The radiation treatments themselves are very focused, targeting just the area where your brain tumour was removed and any other small, unremoved tumours.

Throughout the study, you'll have regular check-ups and medical scans (like MRI scans) to see how you're responding to treatment and to monitor for any side effects. You'll also be asked to fill out questionnaires to assess your quality of life, including your emotional well-being and how you manage everyday activities. The total duration of your participation will depend on how you respond to treatment and how long the researchers need to follow up on your progress.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you would receive closely monitored, state-of-the-art radiation treatment for your resected brain metastasis. You would also contribute valuable information that could help improve care for future patients. Potential risks include side effects from the radiation therapy, which can vary from person to person. These might include fatigue, headaches, or more specific brain-related side effects, which the study team will monitor closely. You always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (232)

  • University of Alabama at Birmingham Cancer Center
    Verified postcode
    Birmingham, United States
  • Anchorage Radiation Therapy Center
    Verified postcode
    Anchorage, United States
  • Banner MD Anderson Cancer Center
    Verified postcode
    Gilbert, United States
  • Banner Thunderbird Medical Center
    Verified postcode
    Glendale, United States
  • Banner-University Medical Center Phoenix
    Verified postcode
    Phoenix, United States
  • Mayo Clinic Hospital in Arizona
    Verified postcode
    Phoenix, United States
  • Mayo Clinic in Arizona
    Verified postcode
    Scottsdale, United States
  • University of Arizona Cancer Center-North Campus
    Verified postcode
    Tucson, United States
  • Mercy Hospital Fort Smith
    Verified postcode
    Fort Smith, United States
  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    Verified postcode
    Jonesboro, United States
  • UC San Diego Moores Cancer Center
    Verified postcode
    La Jolla, United States
  • Los Angeles County-USC Medical Center
    Verified postcode
    Los Angeles, United States

Common questions

What type of cancer is this study for?

This study is for people whose cancer spread to their brain from another part of their body and who have had surgery to remove the brain tumour.

What are the two radiation treatments being compared?

Doctors are comparing a single, large dose of radiation (single fraction) with multiple smaller doses over time (fractionated) for the area where the tumour was removed.

Will I get to choose which radiation treatment I receive?

No, you will be randomly assigned to one of the two treatment groups, like flipping a coin. This ensures the study results are fair.

What is 'quality of life' in this study?

Quality of life in this study refers to how you feel emotionally, physically, and how well you can do your daily activities after treatment. It's measured using special questionnaires.

How long will I be involved in the study?

The duration of your involvement will depend on your individual response to treatment and the study's need for follow-up, which can be long-term to track outcomes.

How to find out more

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

Discussion

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