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Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care

RecruitingPhase 3Ages 18 Years - anyAllGT Medical Technologies, Inc.
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In plain words

What the trial is, and whether it could suit you

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 foll

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Major Criteria Includes the Following: Inclusion Criteria * Patients must be ≥18 years of age. * Have radiographic suspicion of newly diagnosed glioblastoma (GBM). o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL measures but will not be included in the primary and secondary comparative survival and efficacy analyses. * Are medically and surgically appropriate for resection. * Have an estimated Karnofsky Performance Scale (KPS) score of ≥70. * Are able to receive standard of care treatment. Exclusion Criteria * A previous biopsy diagnosis other than IDH wild-type GBM. * Have contraindications to TMZ, magnetic resonance imaging, gadolinium, or non-contrast computed tomography. * Have multi-focal enhancing tumors that cannot be encompassed in one operative field.
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What it tests

  • GammaTile®
  • External Beam Radiation Therapy
  • Temozolomide
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Where

13 sites
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, United States
Keck Medicine of USC
Los Angeles, United States
Advent Health
Orlando, United States
Emory Winship Cancer Institute
Atlanta, United States
Johns Hopkins University
Baltimore, United States
Dartmouth Hitchcock Medical Center
Lebanon, United States
Jersey Shore University Medical Center | Hackensack
Neptune City, United States
Westchester Medical Center
Valhalla, United States

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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