NCT03726359
Phase I Study of Fractionated Stereotactic Radiation Therapy
Recruiting
NAAges 18+InterventionalTreatmentAlbert Einstein College of MedicineInvestigator-initiated
~43 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Fractionated Stereotactic Radiation Therapy (FSRT)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over Within 1 year of initiation of treatment
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Madhur Garg, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Pathologically proven diagnosis of a non-hematological malignancy other than small cell lung cancer within 5 years of registration
Intact (unresected) brain metastases measuring ≥3 cm and ≤ 6 cm in largest dimension on gadolinium contrast enhanced MRI obtained within 30 days prior to registration OR Surgically resected brain metastasis for which postoperative stereotactic radiotherapy is indicated, with expected target measuring ≥3 cm and ≤6 cm in largest dimension
Prior Whole Brain Radiation Therapy (WBRT) is allowed
Age ≥ 18 years
Women of childbearing potential and male participants must practice adequate contraception
History/Physical examination within 30 days prior to registration
Life expectancy \>3 months
Patients are allowed to enroll if previously treated to other lesions with Stereotactic Radiosurgery (SRS)
Patients with multiple lesions are allowed, as long there is one dominant lesion that will be treated with FSRT. Other lesions may be treated concurrently with SRS or FSRT at the discretion of the treating physician but will not contribute to the study endpoints
Exclusion
Patients with definitive leptomeningeal metastases, based on cerebrospinal fluid (CSF) examination
Plan for chemotherapy or targeted agents during treatment. Hormonal therapy, immunotherapy targeting PD-1/PD-L1 axis, and bone supportive therapy may be continued during treatment
Contraindication to enhanced MRI imaging such as implanted metal devices. However, patients with implanted devices which are MRI compatible are allowed
Patients with measurable brain metastasis resulting from small cell lung cancer and germ cell malignancy
Uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, and uncontrolled seizure activity
Previous treatment of the target lesion with radiotherapy
What this trial measures
- Maximum Tolerated Dose (MTD)Within 1 year of initiation of treatment
Determine the maximum tolerated dose (MTD) associated with a 20% probability of dose limiting toxicity (DLT). DLT is defined as grade 3 or higher toxicities (per CTCAE version 4.03; MedDRA version 12.0) that occur within 1 year of treatment start and are either possibly, probably, or definitively related to radiotherapy (RT), and related to the specific symptoms.