Actively Recruiting
Phase I Study of Fractionated Stereotactic Radiation Therapy
Led by Albert Einstein College of Medicine · Updated on 2025-05-22
43
Participants Needed
1
Research Sites
487 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There is a lack of prospective trial data and consensus guidelines describing the use of Fractionated Stereotactic Radiation Therapy (FSRT) in the treatment of brain metastases. There has been no prospective dose escalation study performed to date to determine the maximum tolerated dose (MTD) in patients treated with FSRT. Prescription doses in the series described above ranged from 18 Gy to 42 Gy, delivered in 3 to 12 fractions. The results of this study will be used to plan future Phase II/III studies to determine the efficacy of different dose fractionation schedules of FSRT. The investigator team thus proposes a Phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.
CONDITIONS
Official Title
Phase I Study of Fractionated Stereotactic Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 4 6 cm in largest dimension on gadolinium contrast enhanced MRI within 30 days prior to registration OR surgically resected brain metastasis with expected target measuring 3 cm and 4 6 cm
- Prior Whole Brain Radiation Therapy allowed
- Age 18 years or older
- Women of childbearing potential and male participants must practice adequate contraception
- History and physical examination within 30 days prior to registration
- Life expectancy greater than 3 months
- Patients allowed if previously treated to other lesions with Stereotactic Radiosurgery
- Patients with multiple lesions allowed if one dominant lesion treated with FSRT
You will not qualify if you...
- Definitive leptomeningeal metastases based on cerebrospinal fluid examination
- Planned chemotherapy or targeted agents during treatment (hormonal therapy, immunotherapy targeting PD-1/PD-L1, and bone supportive therapy allowed)
- Contraindication to enhanced MRI imaging such as non-MRI compatible implanted metal devices
- Measurable brain metastasis from small cell lung cancer or germ cell malignancy
- Uncontrolled intercurrent illness such as congestive heart failure, unstable angina, cardiac arrhythmia, or uncontrolled seizures
- Previous treatment of the target lesion with radiotherapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
N
Nitin Ohri, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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