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

Description

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.

Interventions

• GammaTile® (Device)
  GammaTiles are a U.S. FDA-cleared, surgically targeted radiation therapy for patients with certain brain tumors. GammaTile consists of bioresorbable collagen tiles embedded with Cesium-131 (Cs-131) radioactive seeds
• External Beam Radiation Therapy (Radiation)
  External beam radiation therapy (EBRT) is a type of radiation therapy that is standard of care. EBRT uses a machine outside the body to deliver high-energy beams of radiation to cancerous areas within the body
• Temozolomide (Drug)
  TMZ (Chemotherapy) is used as a first-line treatment, often in combination with radiation therapy after surgical resection of the tumor

Eligibility criteria

Conditions

Locations

• HonorHealth Scottsdale Osborn Medical Center — Scottsdale, Arizona, United States
• Keck Medicine of USC — Los Angeles, California, United States
• Advent Health — Orlando, Florida, United States
• Emory Winship Cancer Institute — Atlanta, Georgia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Jersey Shore University Medical Center | Hackensack — Neptune City, New Jersey, United States
• Westchester Medical Center — Valhalla, New York, United States
• East Carolina University — Greenville, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States
• Brown University Health — Providence, Rhode Island, United States
• Inova Schar Cancer Institute — Fairfax, Virginia, United States