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Radiation Therapy
Proton Beam Radiation Therapy for Brain Tumor
Phase 2
Waitlist Available
Led By Sujay A Vora
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
Study Summary
This trial is testing how well 18F-DOPA-PET/MRI works in imaging elderly patients with newly diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of proton beam radiation therapy.
Eligible Conditions
- Glioblastoma
- Malignant Glioma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Incidence of Adverse Events (AEs)
Progression Free Survival
Other outcome measures
Differences in Proton Radiation Planning
Quality of Life (QOL)
Radiotherapy (RT) Treatment Volumes
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)Experimental Treatment8 Interventions
Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning cycles 2, patients receive standard of care temozolomide on days 1-5. Cycles with temozolomide repeat every 28 days for up to 7 cycles in the in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Temozolomide
2010
Completed Phase 3
~1930
Positron Emission Tomography
2008
Completed Phase 2
~2210
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,239 Previous Clinical Trials
3,771,556 Total Patients Enrolled
14 Trials studying Glioblastoma
756 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,321 Total Patients Enrolled
324 Trials studying Glioblastoma
23,129 Patients Enrolled for Glioblastoma
Sujay A VoraPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with a type of brain tumor called glioma, ranging from grades I to III.You are currently taking Avastin for another medical condition.If you are taking any of these medications - amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, or sertraline - please let us know on the study form.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
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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