Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows: * A Screening/Baseline Period of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B. * A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B). * An EBRT Prior to Start Period. This occurs within 10 business days prior to EBRT and Concurrent TMZ Phase. * An EBRT and Concurrent TMZ Phase, which will begin 30 ±10 days post-surgery. EBRT (30 fractions) and TMZ will be administered up to 5 days a week for 6 weeks in Arm A, and EBRT (20 fractions) and TMZ will be administered for up to 5 days a week for 4 weeks in Arm B. TMZ will be administered at a dose of 75 mg/m2/day orally for each Arm. * An Adjuvant TMZ Phase, which begins 28 ±7 days following the EBRT and Concurrent TMZ Phase, and is comprised of six 28-day cycles. TMZ (150-200 mg/m2/day orally) will be administered for the first 5 days of each 28-day cycle for each Arm. Tumor treating fields are allowed but are not mandated during this phase. Up to 6 additional cycles (for a total of 12) can be completed at the discretion of the Investigator. * An Early Discontinuation/Follow-Up Phase will occur 28 ±7 days after completion of Cycle 6 of the Adjuvant TMZ Phase, regardless of the total number of cycles completed or any delays in cycle start. If fewer than six cycles are completed, the first follow-up assessment will occur 28 ±7 days after the last administered dose of adjuvant TMZ. If patient has a qualifying event requiring entrance to Early Discontinuation Phase, the first follow-up assessment will occur as soon as feasible, but within 28 days. For any unscheduled visits, data collected should be documented in the case report form (CRF) and must include, but are not limited to, safety evaluations, survival status, and disease status.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Podejrzenie glejaka mózgu (nowo rozpoznany)
- •Stan zdrowia pozwala na operacyjne usunięcie guza
- •Wynik na skali sprawności co najmniej 70 punktów
- •Możliwość otrzymania standardowego leczenia
✗ Disqualifies
- •Wcześniejsza biopsja wykazująca inny typ guza niż glejak
- •Uczulenie lub przeciwwskazania do chemioterapii TMZ, rezonansu magnetycznego lub gadolinu
- •Wiele guzów w mózgu, których nie można usunąć w jednej operacji
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 9, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (6)
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, United States
Jersey Shore University Medical Center | Hackensack
Neptune City, United States
Westchester Medical Center
Valhalla, United States
East Carolina University
Greenville, United States
Allegheny Health Network
Pittsburgh, United States
Brown University Health
Providence, United States
Trial contact
Kimberly Johnson
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/10/2026.
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