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Brain Metastases in Greater Size - Hypofractionated Options Trial (BIGSHOT)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Feb 3, 2029 → Jan 11, 2031
See other at-risk trials from Medical University of South Carolina

Record History

  1. Primary completion pushed from Feb 3, 2029 to Jan 11, 2031 Completion pushed from Feb 3, 2030 to Jan 11, 2032 · Start date: Feb 3, 2026 to Feb 6, 2026 · Eligibility criteria expanded, about 17 words · 2 more Show 5 more changesShow less
    • Completion pushed from Feb 3, 2030 to Jan 11, 2032
    • Start date: Feb 3, 2026 to Feb 6, 2026
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description revised
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jan 2029 to Feb 3, 2029 · Completion date: Jan 2029 to Feb 3, 2030 · Start date changed from estimate of Jan 2026 to Feb 3, 2026 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Jan 2029 to Feb 3, 2029
    • Completion date: Jan 2029 to Feb 3, 2030
    • Start date changed from estimate of Jan 2026 to Feb 3, 2026
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT07227610
Lead Sponsor Medical University of South Carolina
Conditions Brain Metastases, Cancer (With CNS Involvement)
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov