Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05030298
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Malignant Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Radiosurgery — RADIATION
    Undergo radiosurgery
  • Stereotactic Biopsy — PROCEDURE
    Undergo MRI-guided stereotactic biopsy
  • Temozolomide — DRUG
    Drug
  • Tumor Treating Fields Therapy — PROCEDURE
    Undergo TTF
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Biopsy — PROCEDURE
    Undergo biopsy
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo surgery

Study Details

This phase I trial finds out the possible benefits and/or side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.

Key Dates

Start date
May 23, 2023
Status verified
Apr 2026
Primary completion
Sep 15, 2027
Completion
Sep 15, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (stereotactic biopsy, radiosurgery, surgery)
    Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.

Primary Outcome Measure

Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event [ Time Frame: Up to 4 weeks postoperative radiotherapy ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaPhoenixArizona85054
Clinical Trials Referral Office
[email protected]
855-776-0015
Sujay Vora, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Daniel M. Trifiletti, MD (PRINCIPAL_INVESTIGATOR)

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