Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05030298

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

Led by Mayo Clinic · Updated on 2026-04-22

28

Participants Needed

2

Research Sites

225 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Mayo Clinic in Arizona

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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