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NCT03726359 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Fractionated Stereotactic Radiation Therapy
A Phase 1 study of Brain Metastases, sponsored by Albert Einstein College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT03726359: Recruiting Phase 1 study of Brain Metastases, sponsored by Albert Einstein College of Medicine.
NCT03726359 is a Phase 1 study of Brain Metastases that is actively recruiting participants, run by Albert Einstein College of Medicine. The registered enrollment target is 43 participants, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03726359, a Phase 1 study of Brain Metastases, is actively recruiting participants, sponsored by Albert Einstein College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study 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. The investigator team thus proposes a Phase I study to determine the feasibility and safety of FSRT in patients with brain metastases.
Primary Outcome
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.
Conditions Studied
Interventions
- RADIATION Fractionated Stereotactic Radiation Therapy (FSRT)
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2017-12-25 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What NCT03726359 shows while recruiting
NCT03726359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Brain Metastases appearing as the primary indexed condition, and to 1 intervention - of which Fractionated Stereotactic Radiation Therapy (FSRT) is the first listed.
NCT03726359 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03726359 about?
NCT03726359 is a clinical study titled "Phase I Study of Fractionated Stereotactic Radiation Therapy". 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 pat...
What is the current status of trial NCT03726359?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2017-12-25. Estimated completion is 2027-05.
What conditions does trial NCT03726359 study?
This clinical trial studies the following conditions: Brain Metastases.
What interventions are being tested in trial NCT03726359?
The interventions under investigation include: Fractionated Stereotactic Radiation Therapy (FSRT) (RADIATION).
Who is sponsoring clinical trial NCT03726359?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03726359 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain Metastases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03726359's enrollment target sits among peer trials
43 36th of 67 higher than 32 of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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