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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years after activation
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
428 Previous Clinical Trials
5,306,539 Total Patients Enrolled
Sahaja Acharya, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
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

Frequently Asked Questions

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

Does the clinical trial in question extend to people under 65 years of age?

"According to the prerequisites for this experiment, individuals must be between 6 and 21 years old in order to qualify."

Answered by AI

May I partake in this experiment?

"This clinical trial is accepting 74 applicants, all of whom must possess glioma and fall into the age range between 6 to 21 years old."

Answered by AI

What is the current cap on recruitment for this clinical experiment?

"Correct. Clinicaltrials.gov specifies that this survey is presently enrolling participants, and was initially posted on August 28th 2019. The study necessitates 74 individuals at the single research site to be recruited for participation."

Answered by AI

Is the enrollment process ongoing for this research initiative?

"Affirmative. Clinicaltrials.gov showcases that this medical research, initiated on August 28th 2019 and last updated on November 16th 2022, is now seeking participants. A total of 74 patients are needed to be recruited from a single site."

Answered by AI

Who else is applying?

What state do they live in?
South Dakota
How old are they?
< 18
What site did they apply to?
St. Jude Children's Research Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma
2019. "Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04065776.
All > Glioma
~30 spots leftby Jul 2027
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