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

Recruiting now · Phase 1

Conditions studied: Malignant Glioma

In brief

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 facts

Study ID

NCT05030298

Run by

Mayo Clinic

People needed

28

Starts

2023-05-23

Expected to finish

2027-09-15

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Phoenix, Arizona, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.