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Compares treatment options for Metastatic Malignant Neoplasm in the Brain
Official title SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial
ClinicalTrials.gov ID: NCT05222620
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Any patient with an intact brain metastasis measuring \> 4.0 cm
See the full 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 =\<...
- If the largest lesion measures \>= 2.0 to =\< 4.0 cm in maximal extent the patient will be assigned by chance
- 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
- 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...
- Any patient with an intact brain metastasis measuring \> 4.0 cm
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Albert Lea, Minnesota, United States
- Mankato, Minnesota, United States
- Rochester, Minnesota, United States
- Eau Claire, Wisconsin, United States
- La Crosse, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Albert Lea, Minnesota, United States; Mankato, Minnesota, United States; Rochester, Minnesota, United States; Eau Claire, Wisconsin, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.