NCT05030298 · Mayo Clinic
Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial
What this study is about
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.
View original scientific 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
Radiation Therapy
Undergo radiation therapy
RADIATION
Radiosurgery
Undergo radiosurgery
PROCEDURE
Stereotactic Biopsy
Undergo MRI-guided stereotactic biopsy
DRUG
Temozolomide
Drug
PROCEDURE
Tumor Treating Fields Therapy
Undergo TTF
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Biopsy
Undergo biopsy
PROCEDURE
Therapeutic Conventional Surgery
Undergo surgery
Primary outcome measures
Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event
Time frame: Up 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 toxicity
Time frame: Up 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 radiosurgery
Time frame: Up 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Phoenix, Arizona
- Jacksonville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations