Study on Starting Radiation Immediately with GammaTile During GBM Surgery Compared to Standard Treatment

Sponsor: GT Medical Technologies, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07195591

Provider View

This clinical trial is comparing two approaches for treating glioblastoma multiforme (GBM) after surgery: one with immediate radiation using GammaTile and the other with standard care. The study aims to determine which method is more effective.

Patient Parameters

Program Overview

This study is testing two different ways to treat glioblastoma multiforme (GBM) after surgery. One group of patients will receive standard treatment, while the other group will have GammaTile radiation placed during surgery. The study will follow patients through different phases, including surgery, radiation, and chemotherapy, to see which approach works better.

Description

The study is divided into several phases:

  • Screening/Baseline Period (21 days): Patients will be randomly assigned to one of two groups: Arm A (standard treatment) or Arm B (GammaTile treatment).

  • Perioperative/Operative Phase: Patients in Arm A will have their tumor removed, while those in Arm B will have their tumor removed and receive GammaTile radiation during surgery.

  • EBRT Prior to Start Period: This phase occurs within 10 business days before starting external beam radiation therapy (EBRT) and chemotherapy with temozolomide (TMZ).

  • EBRT and Concurrent TMZ Phase: This phase starts about 30 days after surgery. Arm A will receive 30 sessions of EBRT and TMZ for up to 5 days a week over 6 weeks. Arm B will receive 20 sessions of EBRT and TMZ for up to 5 days a week over 4 weeks. TMZ is taken orally at a dose of 75 mg/m2/day.

  • Adjuvant TMZ Phase: This phase begins about 28 days after the previous phase and includes six 28-day cycles. TMZ is taken orally at a higher dose for the first 5 days of each cycle. Tumor treating fields may be used but are not required. Up to 12 cycles can be completed based on the doctor's decision.

  • Early Discontinuation/Follow-Up Phase: This phase occurs about 28 days after completing the sixth cycle of the Adjuvant TMZ Phase, regardless of the number of cycles completed. If fewer than six cycles are completed, the first follow-up will be 28 days after the last dose of TMZ. If a patient needs to enter this phase early, the first follow-up will be within 28 days.

For any unscheduled visits, important information such as safety, survival, and disease status will be recorded.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
Sponsor85281TempeArizona

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