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Radiation Therapy

Preoperative Radiosurgery for Brain Tumor

Phase 1 & 2
Recruiting
Led By Daniel M. Trifiletti, M.D.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months post-surgery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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
Biopsy
2014
Completed Phase 4
~1090
Temozolomide
2010
Completed Phase 3
~1930
Biospecimen Collection
2004
Completed Phase 2
~1700
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Radiosurgery
2005
Completed Phase 2
~190
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Tumor Treating Fields Therapy
2018
Completed Early Phase 1
~30
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,814 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,766,998 Total Patients Enrolled
Daniel M. Trifiletti, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
30 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this clinical experiment?

"This research has already reached its quota and is no longer recruiting. It was first uploaded on December 1st, 2022 with the last update occurring on November 9th, 2022. If you are looking for alternative trial opportunities, 353 studies involving glioma patients and 207 trials concerning radiosurgery are currently enrolling participants."

Answered by AI

What is the current size of participant enrollment for this trial?

"This research opportunity is no longer recruiting. Initially posted on December 1st 2022, the investigation was most recently modified on November 9th 2022. If seeking out other studies, 353 trials are presently accepting glioma patients and 207 clinical trials require enrollees for Radiosurgery treatments."

Answered by AI

What maladies are typically treated with Radiosurgery?

"Radiosurgery is commonly employed to treat nitrosourea treatment, as well as more complicated medical issues such as advanced directives, refractory neuroblastoma and mycosis fungoides."

Answered by AI

Is this a pioneering research project?

"Radiosurgery has been actively researched since 2002 with the first trial sponsored by Schering-Plough. After Phase 1, it was approved for its second round of trials and today is a part of 207 live studies spread throughout 935 cities and 36 countries."

Answered by AI

Are there any other studies which have been conducted pertaining to Radiosurgery?

"At present, 24 Phase 3 studies related to Radiosurgery are taking place with 207 trials in active operation. In Seoul and Songpa alone there are 4752 sites conducting research on this subject."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Preoperative Radiosurgery for the Treatment of High Grade Glioma, The NeoGlioma Study
2023. "Preoperative Radiosurgery for the Treatment of High Grade Glioma, The NeoGlioma Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05030298.
~24 spots leftby Sep 2025
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