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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure, Other, Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 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

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Minnesota
Mayo Clinic Health System in Albert Lea
NOT_YET_RECRUITING
Albert Lea
Mayo Clinic Health Systems-Mankato
RECRUITING
Mankato
Mayo Clinic in Rochester
RECRUITING
Rochester
Wisconsin
Mayo Clinic Health System-Eau Claire Clinic
RECRUITING
Eau Claire
Mayo Clinic Health System-Franciscan Healthcare
RECRUITING
La Crosse
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2022-03-14
Estimated Completion Date: 2028-02-15
Participants
Target number of participants: 69
Treatments
Other: Arm A (single fraction SRS)
Patients undergo single fraction SRS.
Other: Arm B (fractionated SRS)
Patients undergo fractionated SRS.
Authors
Paul D Brown
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov