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Radiation Therapy

Intensity-Modulated Radiation Therapy for Brain Tumor

Phase 2

Waitlist Available

Led By Nadia N Laack

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 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. diagnosis date occurs prior to randomization by up to 15 years

Awards & highlights

Study Summary

This trialaims to compare MRI & PET scans to measure brain tumor changes, then compare tumor patterns based on scans & treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. diagnosis date occurs prior to randomization by up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. diagnosis date occurs prior to randomization by up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of diagnosis to date of death from any cause censoring patients alive at their last follow-up; patients assessed for survival up to 2 years from randomization. diagnosis date occurs prior to randomization by up to 15 years 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 Participants With Progression-free Survival

Secondary outcome measures

Overall Survival

Quality of Life Brief Fatigue Index (BFI) Change From Baseline

Quality of Life MDASI-BT Change From Baseline

+2 more

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741

30%

Fatigue

20%

Thrombosis

20%

Nausea

20%

Hemoglobin decreased

20%

Lymphopenia

20%

Alanine aminotransferase increased

20%

Hyperglycemia

20%

Hyponatremia

20%

Seizure

10%

Alopecia

10%

Weight loss

10%

Opportunistic infection

10%

Dry mouth

10%

Wound infection [with normal or Grade 1-2 ANC]

10%

Wound infection [with unknown ANC]

10%

Vascular access complication

10%

Wound dehiscence

10%

Dysphagia

10%

Acoustic nerve disorder NOS

10%

Anorexia

10%

Dehydration

10%

Eye disorder

10%

Disease progression

10%

Headache

10%

Hearing loss

10%

Tinnitus

10%

Fracture

10%

Creatinine increased

10%

Hyperkalemia

10%

Hypermagnesemia

10%

Hypoalbuminemia

10%

Muscle weakness left-sided

10%

Memory impairment

10%

Neurological disorder NOS

10%

Taste alteration

10%

Depression

10%

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Pre-Randomization TMZ+RT

Randomized Arm 1: TMZ+RT + Placebo

Randomized Arm 2: TMZ+RT + Bevacizumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-DOPA PETExperimental Treatment3 Interventions

Patients will receive 18FDOPA-PET for radiation treatment planning

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

Fluorine F 18 Fluorodopa

2017

Completed Phase 2

~30

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,213 Previous Clinical Trials

3,766,990 Total Patients Enrolled

Nadia N LaackPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

210 Total Patients Enrolled

Frequently Asked Questions

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

What are some possible side effects of Intensity-Modulated Radiation Therapy?

"Intensity-Modulated Radiation Therapy is thought to be safe based on information from Phase 2 trials. However, there is no data currently available that suggests this intervention is effective."

Answered by AI

Can patients still sign up to participate in this research?

"Currently, this clinical trial is not looking for patients. Although the study was last updated on November 9th, 2022, it is no longer recruiting participants. Fortunately, there are other 365 trials that are still enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma

2017. "The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03242824.