Recruiting
Phase 1

Radiosurgery

Sponsor:

Mayo Clinic

Code:

NCT05030298

Conditions

Malignant Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation Therapy

Radiosurgery

Stereotactic Biopsy

Temozolomide

Tumor Treating Fields Therapy

Study Details

Brief 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. 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

Malignant Glioma

Study ID

NCT05030298

Start date

May 23, 2023

Status verified date

Aug, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (stereotactic biopsy, radiosurgery, surgery)

Patients 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.

Interventions

Radiation Therapy

Undergo radiation therapy

Radiosurgery

Undergo radiosurgery

Stereotactic Biopsy

Undergo MRI-guided stereotactic biopsy

Temozolomide

Drug

Tumor Treating Fields Therapy

Undergo TTF

Magnetic Resonance Imaging

Undergo MRI

Biospecimen Collection

Undergo blood sample collection

Biopsy

Undergo biopsy

Therapeutic Conventional Surgery

Undergo surgery

Primary outcome measure

  • Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event [ Time Frame: Up to 4 weeks postoperative radiotherapy ]
  • Acute clinical toxicity [ Time Frame: Up to 4 weeks postoperative radiotherapy ]
  • Maximum tolerated dose (MTD) of preoperative radiosurgery [ Time Frame: Up to 4 weeks postoperative radiotherapy ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Sujay Vora, MD

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Daniel M. Trifiletti, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-17.