RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)

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

Condition
Metastatic Malignant Neoplasm in the Brain
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic in Arizona, Scottsdale, Arizona, United States, 85259

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224

Albert Lea

Mayo Clinic Health System in Albert Lea, Albert Lea, Minnesota, United States, 56007

Mankato

Mayo Clinic Health Systems-Mankato, Mankato, Minnesota, United States, 56001

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Eau Claire

Mayo Clinic Health System-Eau Claire Clinic, Eau Claire, Wisconsin, United States, 54701

La Crosse

Mayo Clinic Health System-Franciscan Healthcare, La Crosse, Wisconsin, United States, 54601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 willing and able to provide written informed 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Paul D. Brown, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2028-02-15