← Back to Clinical Trials
Recruiting Phase 2 NCT05222620

SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial

Trial Parameters

Condition Metastatic Malignant Neoplasm in the Brain
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 90
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-03-14
Completion 2027-02-15
Interventions
Questionnaire AdministrationStereotactic RadiosurgeryStereotactic Radiosurgery

Brief 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.

Eligibility 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 cons

Related Trials