Radiation Therapy for Pediatric Brain Cancer

Recruiting at 1 trial location

Overseen By Stephanie Perkins, M.D.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Visual impairment, Pacemaker, Shunt, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how radiation therapy affects brain function in children and young adults with brain tumors. Researchers will use brain scans to study changes in brain networks responsible for thinking and memory after radiation treatment. The goal is to determine if these changes lead to cognitive decline, such as difficulties with tasks like remembering things or solving problems. The study seeks participants recently diagnosed with a brain tumor who are set to receive proton radiation therapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that proton radiation therapy is safe for pediatric brain tumor patients?

Research has shown that proton radiation therapy is a promising treatment for children with brain tumors. It effectively controls tumors while causing fewer side effects compared to other treatments. One study found that proton therapy resulted in a 16% rate of hearing loss over five years and a small decrease in IQ. However, the overall survival rate was notable, with 81% of children living at least five years after treatment.

This therapy is considered less harmful than traditional methods, offering better long-term outcomes for children. It is transforming pediatric cancer care by reducing long-term side effects, which is crucial for young patients. While all treatments can have side effects, proton therapy offers a good balance between effectiveness and safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about proton radiation therapy for pediatric brain tumor patients because it offers a more precise way to target tumors while minimizing damage to surrounding healthy tissue. Unlike traditional radiation therapy, which can affect both cancerous and healthy cells, proton therapy uses charged particles that stop at the tumor site, potentially reducing long-term side effects. This precision is particularly important in young patients, as it may lead to better preservation of brain function and development. By focusing on the tumor more accurately, proton therapy holds promise for improving outcomes and quality of life for children and adolescents with brain tumors.

What evidence suggests that proton radiation therapy is effective for cognitive outcomes in pediatric brain tumor patients?

Research has shown that proton radiation therapy, which participants in this trial will receive, effectively treats brain tumors. It targets tumors accurately, protecting the surrounding healthy tissue. Studies have found that this precision leads to better cancer control and fewer side effects. Specifically, proton therapy greatly reduces the risk of mental decline, enhancing patients' quality of life. These benefits make proton therapy a promising choice for treating brain tumors, especially in children and young adults. ^{6 7 8 9 10}

Who Is on the Research Team?

Stephanie Perkins, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

You are between 8 and 21 years old.

You have a newly diagnosed brain tumor that will be treated with proton radiation therapy.

You are able to understand and agree to take part in the research, and your parent or legal guardian also agrees, if needed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Assessment of baseline characteristics of functional network architecture

1 day

1 visit (in-person)

Radiation Therapy

Participants receive proton radiation therapy

6-8 weeks

Follow-up

Participants are monitored for changes in functional network architecture and cognitive performance

1 year

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Radiation Therapy

How Is the Trial Designed?

Group I: Brain tumor patients receiving proton radiation therapy Experimental Treatment 2 Interventions

Patients between 8 and 21 years old (inclusive) with a newly diagnosed primary brain tumor that will be treated with proton radiation therapy

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

Children's Cancer Research Fund

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12237384/

A review of proton beam therapy's role in glioma management PBT significantly reduces neurocognitive decline and enhances quality of life while achieving comparable or superior survival outcomes across various glioma ...

2. withpower.com withpower.com/trial/proton-radiation-therapy-for-brain-tumor-2de77

Proton Radiation Therapy for Brain Tumor Proton radiation therapy is shown to be effective in treating brain tumors by minimizing damage to surrounding healthy tissues, which can help reduce side ...

3. mskcc.org mskcc.org/news/power-precision-proton-therapy-can-target-brain-spine-tumors-fewer-side-effects

Proton Beam Therapy Can Target Brain and Spine Tumors ... “The trial showed that proton craniospinal irradiation resulted in improved control of the cancer in the brain and spine, and better overall ...

4. cureus.com cureus.com/articles/391357-therapeutic-outcomes-and-toxicity-mitigation-of-proton-beam-therapy-in-pediatric-neuro-oncology-a-systematic-review

Therapeutic Outcomes and Toxicity Mitigation of Proton ... Across the 10 studies that met inclusion criteria, proton therapy consistently demonstrated effectiveness in tumor control while significantly ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7066950/

Proton therapy for brain tumours in the area of evidence ... This review details the indication of brain tumors for proton therapy and give a list of the open prospective trials for these challenging tumors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12554329/

Therapeutic Outcomes and Toxicity Mitigation of Proton Beam ... PBT demonstrated equivalent tumor control and survival outcomes compared to conventional therapies while offering significantly reduced risks of ...

7. mayoclinic.org mayoclinic.org/medical-professionals/pediatrics/news/proton-beam-therapy-for-pediatric-cancers/mac-20576795

Proton beam therapy for pediatric cancers Proton beam therapy is transforming pediatric cancer care, with improved outcomes and reduced long-term side effects.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586824005162

Evaluating the safety and efficacy of proton radiotherapy for ... Proton radiotherapy is effective for pediatric intracranial ependymomas. 5-year overall survival reached 81% in treated patients.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5566707/

Proton Beam Therapy for Pediatric Brain Tumor - PMC In a prospective phase II study of PBT in 59 patients with medulloblastoma, Yock et al. reported a hearing loss rate of 16% at 5 years, and an IQ loss of 1.5 ...

10. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0318194

Proton or photon? Comparison of survival and toxicity of two ... Our aim was to determine which of the two major irradiation options, proton (PT) or photon (XRT), was the least harmful yet effective for children with brain ...