Back to search results

NeoGlioma Trial: Preoperative Radiosurgery for High-Grade Glioma

This study, called the NeoGlioma Trial, is looking at whether giving radiosurgery before traditional surgery can help treat high-grade glioma (a type of brain cancer). Radiosurgery uses focused radiation to target the tumor, aiming to kill cancer cells with fewer treatments and less harm to healthy tissue. Participants will receive either standard surgery or radiosurgery followed by surgery. The study will also use Temozolomide (a chemotherapy drug) and Tumor Treating Fields Therapy (a device that creates electric fields to disrupt cancer cell growth). Researchers want to see if this approach is safe, what the best dose of radiosurgery is, and if it improves how well the tumor is controlled. You may be able to join if you are 18 or older and have clear evidence of high-grade glioma. The study plans to enroll 28 people, but its current status is unclear.

Study design
This is a dose-escalation study, meaning the dose of radiosurgery will be carefully increased for different groups of participants. It plans to enroll 28 participants.
What's involved
Participants will undergo an MRI-guided stereotactic biopsy. Within 14 days, they will either have standard surgery or radiosurgery, followed by surgery within another 14 days if they received radiosurgery.
Compensation
Not stated in the trial record.
Follow-up
The study will measure acute side effects up to 4 weeks after postoperative radiotherapy. It will also look at tumor control and overall survival at 12 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05030298

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Mayo Clinic
~28 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Radiation TherapyRadiosurgeryStereotactic BiopsyTemozolomideTumor Treating Fields TherapyMagnetic Resonance Imaging

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event
Measured over Up to 4 weeks postoperative radiotherapy
+2 more outcomes measured

Conditions

Malignant Glioma

Explore related trials

Malignant Glioma

Where it's being run

2 sites across 2 states
Arizona1
Florida1

Study leadership

  • Daniel M. Trifiletti, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of patients experiencing any acute grade 3 or greater unplanned adverse eventUp to 4 weeks postoperative radiotherapy

    Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. The toxicity rate will be estimated using a binomial estimator and a one-sided 95% confidence interval (CI) of the rate will be computed with normal approximation.

  • Acute clinical toxicityUp to 4 weeks postoperative radiotherapy

    Assessed per CTCAE v5.0. The maximum grade for each type of acute adverse events will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Rates will be compared between arms using chi-squared tests.

  • Maximum tolerated dose (MTD) of preoperative radiosurgeryUp to 4 weeks postoperative radiotherapy

    After the trial is completed, the MTD will be based on isotonic regression. The dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate will be selected as the MTD. If there are ties, the higher dose level will be selected when the isotonic estimate is lower than the target toxicity rate; and the lower dose level will be selected when the isotonic estimate is greater than or equal to the target toxicity rate.