Health Trials

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

ConditionsMetastatic Malignant Neoplasm in the BrainMetastatic Malignant Solid Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Questionnaire Administration
  • Stereotactic Radiosurgery
  • Stereotactic Radiosurgery
  • Magnetic Resonance Imaging

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov