RECRUITING

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

Conditions

Metastatic Malignant Neoplasm in the Brain Metastatic Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-03-14

Study Completion:2028-02-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05222620

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Clinical Trials Referral Office

CONTACT

855-776-0015

mayocliniccancerstudies@mayo.edu

Principal Investigator

Paul D. Brown, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224

United States

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, 56007

United States

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, 56001

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701

United States

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-14

Study Completion Date2028-02-15

Study Record Updates

Study Start Date2022-03-14

Study Completion Date2028-02-15

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm