Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Temozolomide for Glioblastoma

This is a Phase 3 prospective, randomly assigned, superiority, open-label, multi-site study. The overview of this study is as follows: * A Screening/Baseline Period of 21 days.

Official registry: https://clinicaltrials.gov/study/NCT07195591 · GT Medical Technologies, Inc. · enrollment listed as 766

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are GammaTile®, External Beam Radiation Therapy, or Temozolomide. The registry lists allocation as randomized. This is a Phase 3 prospective, randomly assigned, superiority, open-label, multi-site study.

They plan to enroll about 766 people at 22 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Randomized Study of Resection and GammaTile® Followed by Concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (GBM)

Interventions: GammaTile®, External Beam Radiation Therapy, Temozolomide

Primary outcome (registry wording): Overall Survival

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Major Criteria Includes the Following:
  • 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 how well it works 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

Public study contact (from the registry)

Kimberly Johnson

(833)662-0044

kjohnson@gammatile.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

22 listed

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FAQ about this NCT record

Is NCT07195591 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07195591?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07195591?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary