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Radiation Therapy

Preoperative Radiosurgery for Brain Tumor

Phase 1 & 2
Recruiting
Led By Daniel Trifiletti
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior history of cranial radiotherapy
Planning to receive adjuvant radiotherapy at enrolling institution
Must not have
Unwillingness to participate in study
Nursing women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months post-surgery
Awards & highlights

Summary

This trial is testing whether radiosurgery before surgery can improve brain tumor control and reduce side effects.

Who is the study for?
Adults with high grade glioma (brain tumor) who are planning surgery and radiotherapy, have good blood counts, no prior cranial radiotherapy, can perform daily activities with minimal help (ECOG PS ≤2), not pregnant or nursing, agree to use contraception if of childbearing potential, and can provide consent. Excludes those with non-MRI compatible devices, recent cancer therapy within 3 months, medical issues preventing surgery or known low-grade gliomas.
What is being tested?
The NeoGlioma Study is testing the effectiveness of radiosurgery before conventional brain tumor surgery. The goal is to see if this approach improves tumor control while reducing side effects compared to traditional methods that involve multiple radiation doses over a longer period.
What are the potential side effects?
Potential side effects include damage to surrounding brain tissue leading to neurological deficits, fatigue from radiation exposure, skin irritation at the treatment site and general discomfort associated with any form of radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had radiation therapy to my head.
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I plan to get additional radiation therapy at the institution where I am enrolling.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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I am scheduled for surgery to remove a brain tumor.
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My brain tumor is a high-grade glioma as confirmed by experts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am willing to participate in the study.
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I am currently breastfeeding.
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I cannot undergo surgery to remove a brain tumor due to health risks.
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I haven't had any cancer treatment in the last 3 months.
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My cancer originates in my spinal cord or brainstem.
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I am of childbearing age and do not plan to use birth control.
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I am willing and able to follow the study's procedures.
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My brain tumor is confirmed to be low or intermediate grade.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event
Secondary outcome measures
Acute clinical toxicity
Overall survival
Radiographic tumor control
+1 more
Other outcome measures
Tumor tissue evaluation of tumor changes

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cohort A (stereotactic biopsy, radiosurgery, surgery)Experimental Treatment9 Interventions
Patients undergo MRI-guided stereotactic biopsy. Patients then undergo radiosurgery over 1 fraction. Within 14 days, patients undergo surgery. Within 4-6 weeks, 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 on study.
Group II: Cohort B (surgery, radiation therapy, chemotherapy)Active Control7 Interventions
Patients undergo surgery. Within 4-6 weeks, 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 on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tumor Treating Fields Therapy
2018
Completed Early Phase 1
~30
Radiation Therapy
2017
Completed Phase 3
~7250
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Biospecimen Collection
2004
Completed Phase 3
~2020
Biopsy
2014
Completed Phase 4
~1090
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Temozolomide
2010
Completed Phase 3
~1880
Radiosurgery
2005
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,775 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,405 Total Patients Enrolled
Daniel TrifilettiPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
19 Total Patients Enrolled

Media Library

Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05030298 — Phase 1 & 2
Malignant Glioma Research Study Groups: Cohort A (stereotactic biopsy, radiosurgery, surgery), Cohort B (surgery, radiation therapy, chemotherapy)
Malignant Glioma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT05030298 — Phase 1 & 2
Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05030298 — Phase 1 & 2
~18 spots leftby Sep 2025
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