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Malignant GliomaPhase 1NCT05030298

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

A Phase 1 study testing Radiation Therapy, Radiosurgery and Stereotactic Biopsy in people with Malignant Glioma, run by Mayo Clinic at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Glioma
What is being tested?
Radiation Therapy, Radiosurgery and Stereotactic Biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesUnited States
Study dates
23 May 2023to 15 Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States2 sites, 2 recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Daniel M. Trifiletti, MD

    Recruiting

  • Mayo Clinic in Arizona

    Phoenix, Arizona, 85054

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Sujay Vora, MD

    Recruiting

Other trials in United States

About this study

Official title: Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the feasibility, safety and maximum tolerated dose (MTD) of preoperative radiosurgery in the treatment of patients with biopsy-proven high-grade glioma prior to conventional therapy.

SECONDARY OBJECTIVES:

  1. Acute clinical toxicity profile using Common Terminology Criteria for Adverse Events (CTCAE) version 5 (defined as within 4 weeks of completion of postoperative radiotherapy.

II. Radiographic tumor control at 12 months following surgery (per Response Assessment in Neuro-Oncology [RANO] criteria).

III. Rate of pseudoprogression at first post radiation scan (RANO criteria). IV. Overall survival at 12 months following surgery.

CORRELATIVE RESEARCH OBJECTIVE:

  1. Evaluation of the tumor repair pathways triggered by radiation, tumor vascular changes, tumor microenvironment immune profiling, cell cultures, and the creation of orthotopic xenograft models for future study.

OUTLINE: This is a dose-escalation study.

Patients undergo magnetic resonance imaging (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 tumor treating fields (TTF) at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.

After completion of study treatment, patients are followed up every 2-3 months for 12 months and then every 3 months for up to 3 years after registration.

Being tested
Radiation Therapy, Radiosurgery, Stereotactic Biopsy, Temozolomide, Tumor Treating Fields Therapy
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated

    Undergo radiation therapy

  • RadiosurgeryRadiation

    Also called Ablation, Radiosurgical, Radiation Surgery

    Undergo radiosurgery

  • Stereotactic BiopsyProcedure or surgery

    Undergo MRI-guided stereotactic biopsy

  • TemozolomideDrug

    Also called CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831

    Drug

  • Tumor Treating Fields TherapyProcedure or surgery

    Also called Alternating Electric Field Therapy, TTF, TTFields

    Undergo TTF

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo surgery

Study groups in NCT05030298
Study groupRoleWhat they receive
Treatment (stereotactic biopsy, radiosurgery, surgery)ExperimentalPatients 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.
Receives: Radiation: Radiation Therapy; Radiation: Radiosurgery; Procedure: Stereotactic Biopsy; Drug: Temozolomide; Procedure: Tumor Treating Fields Therapy; Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Procedure: Biopsy; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event

    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.

    Measured: Up to 4 weeks postoperative radiotherapy

  2. Acute clinical toxicity

    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.

    Measured: Up to 4 weeks postoperative radiotherapy

  3. Maximum tolerated dose (MTD) of preoperative radiosurgery

    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.

    Measured: Up to 4 weeks postoperative radiotherapy

Secondary outcomes (3)

  1. Radiographic tumor control

    Assessed per Response Assessment in Neuro-Oncology (RANO) criteria. The cumulative incidence of radiographic tumor recurrence will be estimated using a competing risks method (Gooley et al.). The competing risks will be death.

    Measured: At 12 months post-surgery

  2. Rate of pseudoprogression

    Assessed per RANO criteria. Data will be summarized as frequencies and relative frequencies overall and by treatment dose. Additionally, the relationship of the pseudoprogression(s) to the study treatment will be taken into consideration.

    Measured: At first post radiation scan

  3. Overall survival

    Overall survival (OS) is defined as the time from study enrollment to death by any cause. Will be estimated with a Kaplan-Meier estimator and curve for patients treated with preoperative radiosurgery. Estimates will be given for specific time points along with 95% CIs.

    Measured: At 12 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2021
  2. Study start23 May 2023
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
The first four patients will be treated by standard of care and all subsequently enrolled patients will undergo preoperative radiosurgery by dose escalation schedule.
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05030298
Sponsor's protocol ID
MC210710
Other IDs
20-013209
Status last verified
Sep 2026
First submitted
23 Aug 2021
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Radiation Therapy, Radiosurgery and Stereotactic Biopsy in people with Malignant Glioma, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event (time frame: Up to 4 weeks postoperative radiotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05030298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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