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Phase I Study of Fractionated Stereotactic Radiation Therapy

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment reopened
    • Enrollment increased: 30 → 43 participants
    • Site details revised
    v10
  2. Phase: Phase 1 to Not applicablev9 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 43 to confirmed 30
    • Primary and study completion dates: May 2027 to Jun 2027
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  3. Interventions: Fractionated Stereotactic Radiation Therapy (Radiation) to Fractionated Stereotactic Radiation Therapy (FSRT) (Radiation)
    • Eligibility criteria shortened, about 14 words
    • Site contact updated
    • Secondary endpoints expanded, about 3 words
    v8
  4. Primary and study completion dates: Feb 2024 to May 2027v7
  5. Primary and study completion dates: Jan 25, 2023 to Feb 2024v6
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  1. Primary completion date: Jan 25, 2022 to Jan 25, 2023
    • Study completion date: Dec 25, 2022 to Jan 25, 2023
    v5
  2. Primary completion date: Dec 25, 2021 to Jan 25, 2022v4
  3. 2 versions Re-verified since Dec 6, 2019, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03726359
Lead Sponsor Albert Einstein College of Medicine
Conditions
(from sponsor)		 Brain Metastases
Related terms Brain Neoplasms
Enrollment 43 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov