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NCT07227610 · ClinicalTrials.gov registry record · Phase 2
Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)
A Phase 2 study of Brain Metastases and Cancer (With CNS Involvement), sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT07227610: Recruiting Phase 2 study of Brain Metastases and Cancer (With CNS Involvement), sponsored by Medical University of South Carolina.
NCT07227610 is a Phase 2 study of Brain Metastases and Cancer (With CNS Involvement) that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 54 participants, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07227610, a Phase 2 study of Brain Metastases and Cancer (With CNS Involvement), is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, phase II trial comparing staged stereotactic radiosurgery (SSRS) versus fractionated stereotactic radiotherapy (FSRT) in patients with large brain metastases (≥2 cm and ≤5 cm). The study aims to evaluate efficacy, safety, and tumor response between these two standard-of-care radiation approaches.
Primary Outcome
For lesions \> 5 mm: Disease progression is defined as at least a 50% increase in the product of the two longest diameters of the target lesion, compared to the smallest product measured for that lesion. For lesions ≤ 5mm on the baseline scan, disease progression is defined as at least a 100% increase in the product of the two longest diameters of the target lesion, compared to the smallest product measured for the same lesion. * Radiation necrosis is defined by: pathologic diagnosis after res
Conditions Studied
Interventions
- RADIATION Staged Stereotactic Radiosurgery (SSRS)
- RADIATION Fractionated Stereotactic Radiotherapy (FSRT)
Study Locations (1)
South Carolina
- Medical University of South Carolina Hollings Cancer Center - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2026-02-03 |
| Est. Completion | 2030-02-03 |
| Phase | Phase 2 |
What NCT07227610 shows while recruiting
NCT07227610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Brain Metastases appearing as the primary indexed condition, and to 2 interventions - of which Staged Stereotactic Radiosurgery (SSRS) is the first listed.
NCT07227610 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT07227610 about?
NCT07227610 is a clinical study titled "Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)". This is a randomized, phase II trial comparing staged stereotactic radiosurgery (SSRS) versus fractionated stereotactic radiotherapy (FSRT) in patients with large brain metastases (≥2 cm and ≤5 cm). The study aims to evaluate efficacy, safety, and tumor response between these two standard-of-care ra...
What is the current status of trial NCT07227610?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2026-02-03. Estimated completion is 2030-02-03.
What conditions does trial NCT07227610 study?
This clinical trial studies the following conditions: Brain Metastases, Cancer (With CNS Involvement).
What interventions are being tested in trial NCT07227610?
The interventions under investigation include: Staged Stereotactic Radiosurgery (SSRS) (RADIATION), Fractionated Stereotactic Radiotherapy (FSRT) (RADIATION).
Who is sponsoring clinical trial NCT07227610?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07227610 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT07227610's enrollment target sits among peer trials
54 25th of 67 higher than 43 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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