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

ConditionGlioblastoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGT Medical Technologies, Inc.

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be ≥18 years of age.

Have radiographic suspicion of newly diagnosed glioblastoma (GBM).

Are medically and surgically appropriate for resection.

Have an estimated Karnofsky Performance Scale (KPS) score of ≥70.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

766 Participants
are divided into 2 treatment groups
Group A: Maximal safe resection followed by EBRT with concurrent TMZ followed by adjuvant TMZ (Arm A)Active comparator 2 interventions
Group B: Maximal safe resection + GammaTile followed by EBRT with concurrent TMZ then adjuvant TMZ (Arm B)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival

The primary endpoint of the study is OS, defined as the day from surgery to death. Patients who are still alive (or lost to follow-up) at the time of data analysis will be censored at the last time point they were known to be alive.

Time frame
Days from surgery to death.

Secondary outcomes

1

Progression Free Survival

To compare PFS, defined as days from surgery to death or disease progression, between the 2 study arms based on the most current RANO Resect Group criteria;

Time frame
Days from surgery to death or disease progression.
2

Time to next unplanned treatment

To compare the time to next unplanned treatment per study arm

Time frame
Time to next unplanned treatment.
3

Performance Status

To assess the performance status up to 24 months

Time frame
24 months.
4

Safety Assessment

To assess the nature, severity, and frequency of AEs between the 2 study arms based on the most current CTCAE criteria

Time frame
Study duration.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GT Medical Technologies, Inc.

Lead sponsor

Source ClinicalTrials.gov
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