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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months post-surgery
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 moreOther 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor believes radiation before surgery won't cause dangerous swelling.I am willing to participate in the study.I have never had radiation therapy to my head.I plan to get additional radiation therapy at the institution where I am enrolling.I can take care of myself and am up and about more than half of my waking hours.I am currently breastfeeding.I cannot undergo surgery to remove a brain tumor due to health risks.I haven't had any cancer treatment in the last 3 months.I am 18 years old or older.My cancer originates in my spinal cord or brainstem.I am scheduled for surgery to remove a brain tumor.My tumor is large or in a critical area, as determined by my doctor.My brain tumor is a high-grade glioma as confirmed by experts.I am of childbearing age and do not plan to use birth control.I am willing and able to follow the study's procedures.My brain tumor is confirmed to be low or intermediate grade.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A (stereotactic biopsy, radiosurgery, surgery)
- Group 2: Cohort B (surgery, radiation therapy, chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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