GammaTile and Stupp in Newly Diagnosed GBM
Public ClinicalTrials.gov record NCT05342883. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pilot Study of Resection and GammaTile Followed by Concomitant External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant in Newly Diagnosed Glioblastoma (GBM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In summary, standard of care postoperative chemoradiation for patients with newly diagnosed GBM does not routinely provide durable local control or prolonged overall survival. As discussed above it seems unlikely that patient outcomes will be significantly improved with radiation dose escalation given at the time of the EBRT boost. However, as most failures are local, improving LC could potentially improve the OS of patients. To do this, we propose a shift in the traditional radiation paradigm. This study will assess the feasibility and tolerability of adding GT radiation therapy as an upfront boost at the time of maximum safe resection, along with the backbone of the current standard of care approach, concomitant and adjuvant temozolomide +/- TTF, for patients with newly diagnosed GBM. GT, a novel brain brachytherapy device utilizing Cs-131 embedded in bioresorbable collagen tiles, offers a more sophisticated carrier and a shorter half-life radioisotope, Cs-131. Use of this device allows for radiation initiation at an earlier time point and a more rapid dose delivery and possibly more effective tumor control particularly for rapidly proliferating tumors such as GBM. Two prospective studies have demonstrated the safety and efficacy of re-irradiation with GT in patients with recurrent GBM. The overarching goal of this single-arm, open label phase 4 study is to determine the feasibility and tolerability of treating patients with GammaTile in combination with the Stupp Protocol and how to proceed with testing this treatment in a future, larger, randomized clinical study. The aims of the study are to demonstrate that the use of GammaTile at the time of surgery is well tolerated and does not delay the start of the Stupp protocol. Efficacy outcomes (e.g., LC, OS, PFS) will also be described.
Study identification
- NCT ID
- NCT05342883
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 61 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 16, 2022
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
- Last update posted
- Sep 4, 2025
2022 – 2027
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHeath Scottsdale Osborn Medical Center | Scottsdale | Arizona | 85251 | — |
| Keck Medicine of USC | Los Angeles | California | 90033 | — |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Advent Health Orlando | Orlando | Florida | 32803 | — |
| Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital | Tampa | Florida | 33606 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| RUSH University | Chicago | Illinois | 60607 | — |
| Indiana University Office of Clinical Research | Indianapolis | Indiana | 46202 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66016 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| University of Minnesota | Minneapolis | Minnesota | 55485 | — |
| St. Louis University Hospital Center | St Louis | Missouri | 63110 | — |
| ECU Health Medical Center - Vidant | Greenville | North Carolina | 27834 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| Brown University Health | Providence | Rhode Island | 02906 | — |
| UTHealth Houston | Memorial Hermann Health System | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05342883, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 4, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05342883 live on ClinicalTrials.gov.