Immediate radiation with GammaTile during glioblastoma surgery versus standard timing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, randomized, open-label, multi-site superiority trial that randomizes adults with newly diagnosed glioblastoma in a 1:2 ratio between standard resection with postoperative external beam radiation and resection with intraoperative GammaTile implantation. In Arm A participants undergo resection followed by EBRT (30 fractions) with concurrent temozolomide (75 mg/m2/day for 6 weeks), while Arm B participants receive resection plus GammaTile implantation followed by a shortened course of EBRT (20 fractions) with the same concurrent temozolomide dose for 4 weeks. All participants then receive adjuvant temozolomide (150–200 mg/m2/day) in six 28-day cycles starting about 28 days after completion of EBRT; patients with IDH-mutant tumors will be followed for safety and quality of life but excluded from the primary comparative analyses. Outcomes will compare survival, local control, and safety between the immediate intraoperative radiation approach and standard timing.

Why it matters

Who can join: the full rules

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.

Where it's running

• HonorHealth Scottsdale Osborn Medical Center
  Scottsdale, Arizona, United States Recruiting
• Keck Medicine of USC
  Los Angeles, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Sutter Health
  San Francisco, California, United States Recruiting
• University of California San Fransico
  San Francisco, California, United States Recruiting
• Advent Health - Colorado
  Littleton, Colorado, United States Recruiting

Study contacts

• Study coordinator: Kimberly Johnson
• Email: kjohnson@gammatile.com
• Phone: (833)662-0044

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.