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Radiation Therapy + Bevacizumab for Recurrent Brain Cancer

N/A
Waitlist Available
Led By Susan L McGovern
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have received one and only one previous course of radiation to the brain, delivered at 1.5 - 2.5 Gy/fraction, one fraction per day
Lansky/Karnofsky performance status score of 50-100
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights

Study Summary

This trial is testing different ways of giving radiation therapy to patients with brain tumors that have come back after previous treatment. The goal is to find the best way to give the therapy with the least amount of side effects.

Who is the study for?
This trial is for patients with brain tumors that have returned after previous radiation therapy. Eligible participants must have had only one prior round of radiation, may have undergone surgery before re-radiation, and should not be pregnant or have recurrent diffuse intrinsic pontine glioma (DIPG). They need a performance status score of 50-100 and recent imaging showing recurrent disease.Check my eligibility
What is being tested?
The study tests the side effects and optimal dose of re-administering radiation therapy to treat recurring brain tumors. It explores whether different methods of delivering radiation can more effectively kill tumor cells. Bevacizumab may also be used at the treating neuro-oncologist's discretion.See study design
What are the potential side effects?
Potential side effects include those typically associated with radiation therapy such as fatigue, skin irritation, hair loss in the treated area, headaches, nausea, and potential damage to surrounding healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had one round of brain radiation at a specific dose.
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I can do most activities but may need help.
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My recent scans show signs of my brain disease coming back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.5 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
Highest grade of central nervous system (CNS) necrosis
Secondary outcome measures
Imaging changes as measured by Advanced Brain Tumor Imaging (ABTI)
Incidence of acute and late toxicities
Overall survival (OS) time
+2 more
Other outcome measures
Symptom burden

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (conventional fractionation)Experimental Treatment2 Interventions
Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (conventional fractionation, bevacizumab)Active Control3 Interventions
Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,474 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,324 Total Patients Enrolled
Susan L McGovernPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02698254 — N/A
Brain Tumor Research Study Groups: Arm I (conventional fractionation), Arm II (conventional fractionation, bevacizumab)
Brain Tumor Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT02698254 — N/A
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02698254 — N/A
~4 spots leftby Jul 2025
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