Proton Beam Radiation for Brain Cancer

Recruiting at 1 trial location

Overseen By Lindsey Brunt, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Visual impairment, Psychiatric, Developmental, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how proton beam radiation therapy affects brain function in children with brain tumors. Researchers aim to determine if this treatment improves thinking skills and memory over time. They will use computer tests to track changes in cognitive abilities before and after the treatment, and then annually. Eligible participants are children aged 4 to 21 with a brain tumor who can use a computer and are set to receive or have already started proton therapy. As a Phase 2 trial, this study focuses on measuring the effectiveness of proton therapy in improving cognitive functions in an initial, smaller group of children.

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 beam radiation therapy is safe for pediatric brain tumor patients?

Research has shown that proton beam radiation therapy (PBRT) is usually well-tolerated by patients with brain tumors. Studies have found that PBRT can target tumors more accurately, reducing radiation exposure to nearby healthy tissues. This precision often results in fewer side effects compared to traditional radiation therapy.

One study found that 29% of patients experienced neurological issues, but skin problems were rare, affecting only 1% of patients. Another source highlights that this therapy can improve overall survival rates while causing less harm to healthy organs.

In summary, while some patients may experience side effects, the precision of PBRT often results in a lower risk of serious problems compared to older radiation methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about proton beam radiation therapy for children with central nervous system tumors because it offers a more precise way to target tumors while sparing healthy surrounding tissue. Unlike traditional radiation therapies that can affect a larger area, proton beams can be controlled to release their energy directly at the tumor site, potentially reducing side effects and damage to developing brains. This precision is particularly important for children, as their brains are still growing, and minimizing harm can lead to better cognitive outcomes long-term.

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

Research has shown that proton beam radiation therapy (PBRT) can protect healthy brain tissue when treating tumors. Studies have found that PBRT targets the tumor directly, reducing radiation exposure to surrounding healthy brain areas. This focused approach is linked to fewer long-term side effects and better preservation of cognitive skills, such as memory and concentration. Early results suggest that children receiving PBRT for brain tumors may experience less decline in these skills compared to those receiving traditional radiation. In this trial, participants will undergo NIH Toolbox Cognitive Battery testing to assess cognitive outcomes. By lowering the risk of harming healthy tissue, PBRT may support better overall cognitive abilities in young patients. ^{2 6 7 8 9}

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

Diagnosis of primary CNS tumor or diagnosis of metastatic disease to the CNS with an expected overall survival of > 1 year. Any prior treatment (chemo, XRT, or surgery) is allowed.

Planning to receive PBRT to treat the CNS tumor. Patients who have already received PBRT for this disease may also be enrolled provided they completed the NIH Toolbox Cognitive Battery prior to the first week of radiation therapy.

Between 4 and 21 years of age (inclusive).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive proton beam radiation therapy (PBRT) with baseline neurocognitive testing completed prior to the end of the first week

6 weeks

1 visit (in-person) for baseline testing

Follow-up

Participants undergo follow-up neurocognitive testing 6-12 months after completion of PBRT and annually thereafter

6-12 months for initial follow-up, then annually

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NIH Toolbox Cognitive Battery
• Proton Beam Radiation Therapy

How Is the Trial Designed?

Group I: Arm 1: NIH Toolbox Cognitive Battery testing Experimental Treatment 1 Intervention

* This study will use the NIH Toolbox Cognitive Battery computer testing software to investigate the cognitive outcomes in children with CNS tumors receiving PBRT. * Participants recruited for the study will complete one 45-minute testing session prior to the completion of the first week of radiation therapy. * They will then complete serial tests 6-12 months after the completion of PBRT and then yearly thereafter.

Proton Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Approved in United States as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Approved in Canada as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Approved in Japan as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Approved in China as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Approved in Switzerland as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9737072/

Proton Beam Therapy for Pediatric Tumors of the Central ... By sparing a large volume of the brain from radiation doses, proton beam therapy aims at reducing long-term side effects and preserving ...

2. advances.massgeneral.org advances.massgeneral.org/oncology/article.aspx?id=1487

Tracking Outcomes in Proton Therapy for Cancer A proton beam delivers a targeted dose of radiation directly to the tumor or desired target—but very little radiation to surrounding tissues.

3. link.springer.com link.springer.com/article/10.1007/s11060-023-04510-4

The effectiveness and safety of proton beam radiation ... Proton beam radiotherapy (PBT) reduces the volume of irradiated tissue outside the tumour target volume which may potentially reduce toxicity.

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14582-2

Proton beam radiation therapy and the overall survival of adult ... Early cognitive outcomes following proton radiation in pediatric patients with brain and central nervous system tumors. Int J Radiat Oncol ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301622034186

Preservation of Neurocognition after Proton Beam ... Proton beam radiation therapy reduces dose to healthy brain tissue and thereby decreases the risk of treatment-related decline in neurocognition.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12275320/

Proton Beam Therapy & CNS Tumor Survival Conclusions. The use of PBT in patients diagnosed with CNS tumors was associated with improved OS compared to photon RT. In the stratified ...

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

Evaluating the safety and efficacy of proton radiotherapy for ... 5-year overall survival reached 81% in treated patients. ... Neurological complications were observed in 29% of patients. ... Low incidence of dermatological (1%) ...

8. cancer.gov cancer.gov/news-events/cancer-currents-blog/2020/proton-therapy-safety-versus-traditional-radiation

Is Proton Therapy Safer than Traditional Radiation? - NCI After 3 years, 46% of patients in the proton therapy group and 49% of those in the traditional radiation therapy group were cancer free. Fifty- ...

9. 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 allows reduction in radiation dose to healthy tissues and organs while delivering the required dose to the tumor.