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NCT04065776 · ClinicalTrials.gov registry record · NA
Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma
A NA study of Glioma and Pilocytic Astrocytoma, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 2
- Study locations
NCT04065776 is a NA study of Glioma and Pilocytic Astrocytoma that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 74 participants, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (65% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04065776, a NA study of Glioma and Pilocytic Astrocytoma, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 2
- Study locations
Study Summary
Low-grade gliomas (LGGs) are the most common brain tumors in children, and a subset of these tumors are treated definitively with focal radiation therapy (RT). These patients often survive for many years after receiving RT and experience late deficits in memory. Verbal recall is an important measure of memory and is associated with other important functional outcomes, such as problem-solving, independence of every-day functioning, and quality of life. Decline in memory, as measured by verbal recall, is associated with RT dose to the hippocampi. Therefore, this phase II study investigates the feasibility of reducing RT doses to the hippocampi (i.e., hippocampal avoidance \[HA\]) by using proton therapy for midline or suprasellar LGGs. Primary Objective: * To determine the feasibility of HA with proton therapy in suprasellar or midline LGGs. Feasibility will be established if 70% of plans meet the first or second dose constraints shown below. 1. First priority RT dose constraints for bilateral hippocampi: volume receiving 40 CGE (V40CGE) ≤ 25%, dose to 100% of Hippocampus (D100%) ≤ 5CGE. 2. Second priority RT dose constraints for bilateral hippocampi: V40CGE ≤ 35%, D100% ≤ 10 CGE. Secondary Objectives: * To estimate the 3-year event-free-survival (EFS) for LGGs treated with HA. * To estimate the change in California Verbal Learning Test short-term delay (CVLT-SD) from baseline to 3 years and from baseline to 5 years * To compare CVLT-SD and Cogstate neurocognitive scores in patients with proton therapy plans that: (1) meet first priority RT dose constraints, (2) meet second priority RT dose constraints but not first priority RT dose constraints, and (3) that did not meet either first or second RT priority dose constraints Exploratory Objectives: * To describe the change in overall cognitive performance from baseline to 3 years and from baseline to 5 years with an age appropriate battery, including gold standard measures shown in the published studies to
Conditions Studied
Interventions
- RADIATION Hippocampal-avoidance proton therapy
Study Locations (2)
Minnesota
- Mayo Clinic - Rochester
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-08-28 |
| Est. Completion | 2028-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04065776
The ClinicalTrials.gov registry entry for NCT04065776 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 87 other Glioma trials with a reported enrollment target (65% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which Hippocampal-avoidance proton therapy is the first listed.
NCT04065776 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Minnesota, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04065776 about?
NCT04065776 is a clinical study titled "Evaluation of Hippocampal-Avoidance Using Proton Therapy in Low-Grade Glioma". Low-grade gliomas (LGGs) are the most common brain tumors in children, and a subset of these tumors are treated definitively with focal radiation therapy (RT). These patients often survive for many years after receiving RT and experience late deficits in memory. Verbal recall is an important measure...
What is the current status of trial NCT04065776?
This trial is currently recruiting. It is a NA study. The enrollment target is 74 participants. The study started on 2019-08-28. Estimated completion is 2028-07.
What conditions does trial NCT04065776 study?
This clinical trial studies the following conditions: Glioma, Pilocytic Astrocytoma, Pleomorphic Xanthoastrocytoma, Ganglioglioma, Diffuse Astrocytoma.
What interventions are being tested in trial NCT04065776?
The interventions under investigation include: Hippocampal-avoidance proton therapy (RADIATION).
Who is sponsoring clinical trial NCT04065776?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04065776 being conducted?
This trial has 2 study locations across Minnesota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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