Actively Recruiting
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Led by GT Medical Technologies, Inc. · Updated on 2026-04-30
766
Participants Needed
4
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years of age or older
- Have radiographic suspicion of newly diagnosed glioblastoma (GBM)
- Medically and surgically appropriate for tumor resection
- Estimated Karnofsky Performance Scale (KPS) score of 70 or higher
- Able to receive standard of care treatment
You will not qualify if you...
- Previous biopsy diagnosis other than IDH wild-type glioblastoma
- Contraindications to temozolomide, MRI, gadolinium, or non-contrast CT
- Multi-focal enhancing tumors that cannot be removed in one surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, United States, 85251
Actively Recruiting
2
HMH Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
3
Westchester Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
4
Brown University Health
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
K
Kimberly Johnson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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