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Brief Title: Phase I Study of Fractionated Stereotactic Radiation Therapy
Official Title: Phase I TITE-CREM Dose Escalation Study of Fractionated Stereotactic Radiation Therapy (FSRT) in Unresected Brain Metastases
Study ID: NCT03726359
Brief Summary: 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. We thus propose a phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Montefiore Medical Center, Bronx, New York, United States
Name: Madhur Garg, MD
Affiliation: Montefiore
Role: PRINCIPAL_INVESTIGATOR