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Proton Beam Therapy

Proton Radiotherapy for Pediatric Brain Cancer

Phase 2
Waitlist Available
Led By Torunn I. Yock, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy proven low grade glioma or astrocytoma, ependymoma, craniopharyngioma, meningioma, neurocytoma, medulloblastoma or gangliogliomas or other rare tumor requiring tumor bed or tumor irradiation
Age between 1-25 years
Must not have
Participants with known spinal or distant metastases. Patients with ependymoma, medulloblastoma or germinoma must have metastatic workup including spine MRI to rule out metastases
Participants who have had radiotherapy to the site to be treated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trialis looking at a different radiation technique, proton radiotherapy, which aims to target brain tumors while sparing normal tissue from radiation-induced side effects.

Who is the study for?
This trial is for children and young adults aged 1-25 with certain brain tumors (like high-grade glioma, but not GBM, or non-disseminated ATRT) who haven't had radiotherapy in the same area before. They should have a life expectancy over a year and be willing to use contraception if applicable. It's not for those with metastases, uncontrolled illnesses that could affect participation, pregnant/breastfeeding women, or those unable to contribute to neurocognitive outcomes.
What is being tested?
The study tests proton radiotherapy on pediatric brain tumors needing partial brain irradiation. Proton therapy targets tumors more precisely than standard radiation, potentially sparing healthy tissue and reducing side effects. The effectiveness of this technique compared to conventional methods is being evaluated.
What are the potential side effects?
While proton radiotherapy aims to reduce side effects by sparing normal tissues from radiation exposure compared to standard therapy, potential side effects may still include skin reactions at the treatment site, fatigue, headaches, hair loss around the treated area and possible short-term cognitive changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed diagnosis of a specific brain tumor type.
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I am between 1 and 25 years old.
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I can care for myself but may not be able to do active work or play.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer that has spread to my spine or other distant areas.
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I have received radiotherapy on the area that needs treatment.
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I do not have severe neurological issues or language barriers preventing my participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Endocrine dysfunction
Neurocognitive sequelae
Secondary study objectives
Acute effects
Auditory function
Disease control

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: Proton RadiotherapyExperimental Treatment1 Intervention
Proton Radiotherapy

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,928 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,182 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,107 Previous Clinical Trials
357,028 Total Patients Enrolled

Media Library

Proton radiotherapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01288235 — Phase 2
Brain Tumor Research Study Groups: Proton Radiotherapy
Brain Tumor Clinical Trial 2023: Proton radiotherapy Highlights & Side Effects. Trial Name: NCT01288235 — Phase 2
Proton radiotherapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01288235 — Phase 2
~5 spots leftby Sep 2025
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