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RecruitingPhase 2

Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction

A Double-Blind Phase II Randomized Study of Adaptively Delivered LINAC-Based Stereotactic Radiation for Volatile Brain Metastases With Same-Day Planning and Margin Reduction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will have a preliminary stereotactic treatment plan created from a diagnostic brain MRI indicating the need for treatment."
  • "On the day of treatment (SRS) or start of treatment (SRT), a repeat MRI brain will be performed for planning purposes on an MRI simulator."
  • "A synthetic computed tomography (CT) scan will be generated from the new MRI."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether planning and giving focused brain radiation on the same day is practical and works well. It is for adults with cancer that has spread to the brain and is growing or near swelling or other changes that could shift the tumor. Participants are assigned by chance to radiation with either a 1-millimeter extra border around the tumor or no extra border.

The goal of this study is to evaluate the feasibility and effectiveness of same-day radiation planning and treatment. The study will shorten the time interval between radiation planning (radiation mapping) and radiation treatment. The intent of this shorter time interval is to increase the likelihood that the brain metastases being treated remain fully within the high-dose radiation fields. Participants will be randomized to receive brain-directed stereotactic radiation with a 1mm margin or 0mm margin, have their simulation/radiation planning imaging on the same day that brain-directed stereotactic radiation is delivered, and have repeat simulation/radiation planning scans during the course of treatment if more than 2-3 days have elapsed since the most recent scans.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Have a solid cancer confirmed by a tissue sample, with at least one tumor in the brain that scans or tissue tests show is cancer that has spread.
  • The brain tumor must meet at least one condition: grow an average of 1 millimeter per week on the last two MRI scans; be within 1 centimeter of brain swelling; be within 5 centimeters of a space left by surgery in the past 30 days; or be within 5 centimeters of another source that could shift it.
  • Have a score of at least 60 on a scale of daily function, meaning you can meet most personal needs but may need some help.
  • Your study doctor must expect you to live at least 3–6 months.
  • Be able to understand the study and willing to sign a consent form on paper or through an approved electronic system.

Who can't join

  • Cannot tolerate a brain MRI scan.
  • Cannot receive gadolinium, a dye used for MRI scans.
  • Have end-stage kidney disease, when the kidneys no longer work well enough.
  • Have confirmed, widespread cancer in the thin layers covering the brain and spinal cord.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Participants must have a biopsy proven solid malignancy with at least one intact, residual or recurrent, intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis meeting one of the following criteria: 1. Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment 2. Abutment, to within 1.0cm, of a region of intracranial edema 3. Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment 4. Proximity (within 5.0cm) to another source of physical displacement 2. Age of at least 18 years 3. Karnofsky performance status of at least 60 4. Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI 5. Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF/HCC approved eConsent medium Exclusion Criteria: 1. Participants who cannot tolerate a brain MRI 2. Patients who cannot receive gadolinium 3. Participants with end stage renal disease 4. Participants with widespread, definitive leptomeningeal disease 5. Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study as well

Study sites (1)

MA