Trials / Withdrawn
WithdrawnNCT05900908
Post-operative Adjuvant Therapy w/wo GammaTile + Systemic Therapy
A Randomized Controlled Trial of Surgical Resection With GammaTile Therapy and Adjuvant Systemic Therapy Compared to Surgical Resection and Adjuvant Systemic Therapy at First Recurrence in Glioblastoma.
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- GT Medical Technologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2026-06-01
- Completion
- 2028-06-01
- First posted
- 2023-06-13
- Last updated
- 2025-04-10
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05900908. Inclusion in this directory is not an endorsement.