Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial
NCT ID: NCT05030298
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
28 participants
INTERVENTIONAL
2023-05-23
2027-09-15
Brief Summary
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Detailed Description
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I. 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:
I. 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:
I. 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.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Daniel M. Trifiletti, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Phoenix, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2021-08848
Identifier Type: REGISTRY
Identifier Source: secondary_id
20-013209
Identifier Type: OTHER
Identifier Source: secondary_id
MC210710
Identifier Type: -
Identifier Source: org_study_id
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