Post-operative Adjuvant Therapy w/wo GammaTile + Systemic Therapy
NCT05900908 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2025-04-10
Summary
To compare surgical tumor removal and GammaTile therapy followed by adjuvant systemic therapy (bevacizumab or lomustine) to surgical tumor removal followed by adjuvant systemic therapy (bevacizumab or lomustine) without GammaTile therapy.
Conditions
Interventions
- DEVICE
-
Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)
GammaTiles are a permanently implanted radiation device consisting of Cs-131 seeds positioned within a collagen tile
- RADIATION
-
Stereotactic Radiation Therapy
External Beam Radiation Therapy
Sponsors & Collaborators
-
GT Medical Technologies, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-31
- Primary Completion
- 2026-06-30
- Completion
- 2028-06-30
- FDA Device
- Yes
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