Same-day stereotactic radiation with reduced planning margins for growing or changing brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase 2 study enrolls adults with biopsy-proven solid tumor brain metastases that are growing or causing local displacement and randomizes them to stereotactic radiation using either a 0 mm or 1 mm planning target volume margin. A preliminary plan is generated from a diagnostic MRI, then on the day of treatment a repeat MRI is taken, a synthetic CT is created, and the plan is adapted to the new imaging before delivering stereotactic radiosurgery or radiotherapy. Repeat simulation scans are obtained during the course of treatment if more than 2–3 days have passed since the most recent scans. The trial aims to determine feasibility, the effect of shortened planning-to-treatment time and tighter margins on local control, and rates of radiation necrosis.

Why it matters

Who can join: the full rules

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

Where it's running

• Brigham and Women's Hospital / Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Ayal A Aizer, MD, MHS — Dana-Farber/Brigham and Women's Cancer Center
• Study coordinator: Ayal A Aizer, MD, MHS
• Email: aaaizer@partners.org
• Phone: (617) 732-7560

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.