Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)
Mayo Clinic
Summary
This phase II trial compares the effect of single fraction stereotactic radiosurgery to fractionated stereotactic radiosurgery for the treatment of patients with cancer that has spread to the brain (metastatic brain disease). Stereotactic radiosurgery (SRS) is a form of radiation therapy that focuses high-power energy on a small area of the body. This trial is being done to determine if single (one) fraction stereotactic radiosurgery is better than fractionated stereotactic radiosurgery or vice versa in controlling tumor and side effects in patients with tumors that have spread to the brain.
Description
PRIMARY OBJECTIVE: I. To ascertain if the composite endpoint of cumulative treatment failure, defined by time to either local failure or symptomatic radiation brain necrosis of the largest brain metastasis (target lesion), is increased with fractionated stereotactic radiosurgery (FSRS) compared to single fraction stereotactic radiosurgery (SSRS). SECONDARY OBJECTIVES: I. To ascertain whether there is improved overall survival in patients who undergo FSRS compared to patients who receive SSRS. II. To tabulate and descriptively compare the post-treatment adverse events associated with the in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- OtherQuestionnaire Administration
Ancillary studies
- RadiationStereotactic Radiosurgery
Undergo single fraction SRS
- RadiationStereotactic Radiosurgery
Undergo fractionated SRS
- ProcedureMagnetic Resonance Imaging
Undergo MRI
Locations (7)
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic in FloridaJacksonville, Florida
- Mayo Clinic Health System in Albert LeaAlbert Lea, Minnesota
- Mayo Clinic Health Systems-MankatoMankato, Minnesota
- Mayo Clinic in RochesterRochester, Minnesota
- Mayo Clinic Health System-Eau Claire ClinicEau Claire, Wisconsin