Comparing single and fractionated stereotactic radiosurgery for brain metastases treatment
Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)
This study is testing whether a single session of targeted radiation or multiple sessions is better for treating patients with brain tumors that have spread from other cancers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation, immunotherapy |
| Locations | 7 sites (Scottsdale, Arizona and 6 other locations) |
| Trial ID | NCT05222620 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with intact brain metastases measuring between 2.0 cm and 4.0 cm from an extra-cerebral tumor site.
Not a fit: Patients with previously treated brain metastases or those with lesions outside the specified size range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify the more effective treatment method for controlling brain tumors in patients with metastatic cancer, potentially improving survival and quality of life.
How similar studies have performed: Previous studies have explored stereotactic radiosurgery techniques, but this specific comparison of single versus fractionated approaches is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Scottsdale, Arizona and 6 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.