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Proton Beam Therapy

Proton Therapy for Brain Tumor

N/A
Recruiting
Led By Sahaja Acharya, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be at least 6 years but less than 22 years of age at the time of enrollment.
Patients must have a diagnosis of pilocytic astrocytoma, pilomyxoid astrocytoma, pleomorphic xanthoastrocytoma, ganglioglioma, optic pathway glioma, diffuse astrocytoma, low-grade neuroepithelial tumor, low-grade glioneuronal tumor or LGG, or not otherwise specified (NOS).
Must not have
Patients with evidence of metastatic disease are not eligible.
Patients with tumors in the spine or cervicomedullary junction.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline evaluation date, 3 years after treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at whether proton therapy can help reduce side effects from radiation treatment for low-grade gliomas in children.

Who is the study for?
This trial is for children and young adults aged 6 to less than 22 with certain low-grade brain tumors, including pilocytic astrocytoma and diffuse astrocytoma. Participants must have measurable disease, be able to undergo MRI scans, and not have had previous CNS radiation or tumor invasion into the hippocampus. They should also have adequate organ function and controlled seizures if present.
What is being tested?
The study tests whether proton therapy that avoids the hippocampi can help treat brain tumors without harming memory. It aims to see if this approach is feasible by meeting specific radiation dose constraints on the hippocampi while estimating survival rates and changes in verbal recall over time.
What are the potential side effects?
Potential side effects may include typical risks associated with radiation therapy such as fatigue, hair loss at treatment site, headaches, nausea, skin irritation near treated area but are expected to be reduced due to precision of proton therapy avoiding sensitive areas like the hippocampus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 21 years old.
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I have been diagnosed with a specific type of low-grade brain tumor.
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My diagnosis, not related to specific brain areas, is confirmed by tissue examination.
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My brain tumor's presence or recurrence has been confirmed by imaging tests.
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I am mostly active and can care for myself.
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I am not currently on chemotherapy or targeted therapy.
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My diagnosis was confirmed through a biopsy or imaging.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has not spread to other parts of my body.
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My cancer is located in my spine or near the base of my skull.
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My brain tumor does not fall into the excluded WHO grade II categories.
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My cancer is visible and measures at least 1 cm on an MRI.
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I have had surgery to remove one or both of my hippocampi.
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My cancer has not spread to my hippocampus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline evaluation date, 3 years after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline evaluation date, 3 years after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of plans meet the first or second dose constraints.
Secondary study objectives
CVLT-SD neurocognitive scores
Cogstate neurocognitive scores
EFS of LGGs treated with HA
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hippocampal-avoidance proton therapyExperimental Treatment1 Intervention
Hippocampal-avoidance proton therapy

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,407 Total Patients Enrolled
Sahaja Acharya, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
1 Previous Clinical Trials
338 Total Patients Enrolled
Thomas Merchant, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Hippocampal-avoidance proton therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04065776 — N/A
Optic Pathway Glioma Research Study Groups: Hippocampal-avoidance proton therapy
Optic Pathway Glioma Clinical Trial 2023: Hippocampal-avoidance proton therapy Highlights & Side Effects. Trial Name: NCT04065776 — N/A
Hippocampal-avoidance proton therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04065776 — N/A
~24 spots leftby Jul 2027
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