Comparing single and fractionated stereotactic radiosurgery for brain metastases treatment

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 phase II trial investigates the effectiveness of single fraction stereotactic radiosurgery (SRS) versus fractionated stereotactic radiosurgery (FSRS) in treating patients with metastatic brain tumors. The primary objective is to determine if FSRS leads to a higher rate of treatment failure compared to SRS, while secondary objectives include assessing overall survival, adverse events, and quality of life outcomes. Patients will be monitored for local and distant brain failure patterns and rates of radiation necrosis. The study aims to provide insights into the optimal radiation therapy approach for patients with brain metastases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>= 18 years old
* Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.)

  * Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible
* Size of brain metastases

  * At least one intact metastasis (not previously treated with radiosurgery) must measure \>= 2.0 cm and =\< 4.0 cm in maximal extent on the contrasted pre-treatment magnetic resonance imaging (MRI) brain scan obtained =\< 28 days prior to registration
  * If the largest lesion measures \>= 2.0 to =\< 4.0 cm in maximal extent the patient will be randomized
* Able to undergo contrast enhanced MRI brain
* Negative urine or serum pregnancy test completed =\< 7 days prior to registration, for women of childbearing potential only
* Patient is willing and able to provide written informed consent or have a legally Authorized Representative (LAR) who is responsible for the care and well-being of the potential study participant provide consent.
* Karnofsky performance status (KPS) \>= 50
* Eastern Cooperative Oncology Group (ECOG) performance score of (PS) \>= 2
* Past radiosurgery or resection is allowed as long as no definitive evidence of progression in these locations

  * Note: Repeat radiosurgery to the same location/lesion is not allowed on this protocol

Exclusion Criteria:

* Any patient who has received previous whole brain radiation
* Any brain metastasis that is located in the brainstem measuring \>= 2.0 cm in maximal extent
* Any patient with definitive evidence of leptomeningeal metastasis (LMD)

  * NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion
* Any patient with an intact brain metastasis measuring \> 4.0 cm

Where it's running

• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting
• Mayo Clinic Health Systems-Mankato
  Mankato, Minnesota, United States Recruiting
• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting
• Mayo Clinic Health System-Eau Claire Clinic
  Eau Claire, Wisconsin, United States Recruiting
• Mayo Clinic Health System-Franciscan Healthcare
  La Crosse, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Paul D. Brown, MD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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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.