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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

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
Computed Tomography
2017
Completed Phase 2
~2720
Proton Beam Radiation Therapy
2013
Completed Phase 2
~110
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Temozolomide
2010
Completed Phase 3
~1930
Positron Emission Tomography
2008
Completed Phase 2
~2240

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,741 Total Patients Enrolled
14 Trials studying Glioblastoma
756 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,110 Total Patients Enrolled
322 Trials studying Glioblastoma
23,072 Patients Enrolled for Glioblastoma
Sujay A VoraPrincipal InvestigatorMayo Clinic

Media Library

Proton Beam Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03778294 — Phase 2
Glioblastoma Research Study Groups: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
Glioblastoma Clinical Trial 2023: Proton Beam Radiation Therapy Highlights & Side Effects. Trial Name: NCT03778294 — Phase 2
Proton Beam Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03778294 — Phase 2

Frequently Asked Questions

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

What potential hazards arise from the administration of Temozolomide?

"Based on the available evidence, Temozolomide's safety was estimated to be a 2. This is due to it being in the Phase 2 trial stage, indicating that there is some data supporting its security but none concerning efficacy."

Answered by AI

Are there any other scientific experiments involving Temozolomide that have been completed?

"Currently, 207 scientific investigations into Temozolomide are being executed; 24 of them inhabit Phase 3. The majority of occurrences can be observed in Seoul and Songpa, but the drug is also being studied at 4752 locations worldwide."

Answered by AI

Is this study pioneering in its approach?

"According to the databases, there are 207 live studies for Temozolomide that span 36 countries and 935 cities. This medication has been monitored since 2002 when Schering-Plough conducted a Phase 2 study with 60 participants. Since then, 623 trials have concluded their research."

Answered by AI

For which conditions is Temozolomide a common remedy?

"Nitrosourea-based treatments are often treated with temozolomide. This compound can also be beneficial in the management of refractory directives, advance mycosis fungoides, and intractable neuroblastoma."

Answered by AI

What is the current enrollment size for this clinical trial?

"This clinical trial is no longer enrolling participants. It was first posted on March 28th 2019 and the last edits were made September 20th 2022. At present, there are 707 trials researching glioblastoma and 207 trials with Temozolomide which have open recruitment periods."

Answered by AI

Are there any slots available to join this experiment?

"At this moment, no further patients are being sought for enrollment. This trial was initially posted on March 28th 2019 and finalized its updates in September 20th 2022. If you're looking for other studies related to glioblastoma or Temozolomide, there are currently 707 and 207 active trials respectively."

Answered by AI
~7 spots leftby Apr 2025