RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Mayo Clinic • ClinicalTrials.gov ID: NCT05030298

Registry updated: 2026-09-30

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Description

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.

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

Eligibility criteria

Inclusion Criteria: * Age \>= 18 years * Clear clinical and radiographic evidence of primary high grade glioma (HGG) as judged by the Mayo multidisciplinary neuro-oncology team (World Health Organization \[WHO\] grade III-IV, including glioblastoma) regardless of IDH and MGMT status * Patients who underwent a previous biopsy confirming high grade glioma are eligible for enrollment * Planned neurosurgical resection of tumor * Judged to not be at risk of significant clinical risk (i.e. herniation) with radiation-induced edema prior to resection * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Negative pregnancy test done =\< 14 days prior to registration, for women of childbearing potential only. Patients over 50 years of age who decline pregnancy testing are still eligible without a pregnancy test. * Ability to complete questionnaire(s) by themselves or with assistance * Provide written informed consent * Willing to receive adjuvant radiotherapy at enrolling institution at the time of registration * Willing to provide tissue and/or blood samples for correlative research purposes Exclusion Criteria: * Any of the following: * Pregnant women * Nursing women who are unwilling to cease during therapy * Men or women of childbearing potential who are unwilling to employ adequate contraception * Prior history of cranial radiotherapy * Unwillingness to participate in study * Investigator discretion that enrollment on the study would pose undo harm or risk to the patient * Non-MRI compatible implanted medical device * Use of systemic anti-cancer therapy within the previous 3 months * Medical contraindication to craniotomy and tumor resection * Pathologic confirmation of grade I-II glioma, brain metastasis, or other brain tumor * Note: Patients with a history of grade I-II glioma are eligible if they have only received surgery as treatment and now there is concern for transformation to grade III-IV tumor * Primary spinal cord glioma or primary brainstem glioma * Residual tumor of excessive volume or eloquent location per investigator discretion * Patients who are unwilling or unable to comply with study procedures

Conditions

Malignant Glioma

Locations

Mayo Clinic in Arizona — Phoenix, Arizona, United States
Mayo Clinic in Florida — Jacksonville, Florida, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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