Proton Radiotherapy for Pediatric Brain Cancer

Recruiting at 1 trial location

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Disqualifiers: Prior radiotherapy, Metastases, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Some patients with brain tumors receive standard radiation to help prevent tumor growth. Although standard radiation kills tumor cells, it can also damage normal tissue in the process and lead to more side effects. This research study is looking at a different form of radiation called proton radiotherapy which helps spare normal tissues while delivering radiation to the tumor or tumor bed. Proton techniques irradiate 2-3 times less normal tissue then standard radiation. This therapy has been used in treatment of other cancers and information from those other research studies suggests that this therapy may help better target brain tumors then standard radiation.

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.

Is proton radiotherapy safe for children with brain cancer?

Proton radiotherapy is generally considered safe for children with brain cancer, with studies showing good outcomes and a lower risk of side effects compared to traditional radiation. However, there are some risks, such as brainstem injury and moyamoya syndrome, which is a rare blood vessel disorder, especially in younger children. ^{1 2 3 4 5}

How is proton radiotherapy different from other treatments for pediatric brain cancer?

Proton radiotherapy is unique because it uses protons instead of traditional X-rays (photons) to target tumors, allowing for more precise delivery of radiation that spares healthy tissues. This reduces the risk of long-term side effects and secondary cancers, which is particularly important for children. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Proton radiotherapy for pediatric brain cancer?

Proton radiotherapy is effective for treating pediatric brain cancer because it can target tumors more precisely, reducing damage to healthy tissues and lowering the risk of side effects. Studies show that it offers better protection for developing tissues compared to traditional radiation, which is especially important for children. ^{2 6 11 12 13}

Who Is on the Research Team?

Torunn Yock, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a confirmed diagnosis of a specific brain tumor type.

I have a high-grade glioma (not GBM) or ATRT with complete surgery and no spread.

I am between 1 and 25 years old.

Exclusion Criteria

I have cancer that has spread to my spine or other distant areas.

I do not have any illnesses that would stop me from following the study's requirements.

I have received radiotherapy on the area that needs treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Proton Radiotherapy

Participants receive proton radiotherapy 5 days per week at the Francis H. Burr Proton Therapy Center. The duration depends on tumor type, location, and treatment tolerance.

Weekly physical exams during treatment

Follow-up

Participants are monitored for neurocognitive, neuroendocrine, and ototoxicity outcomes, as well as disease control and auditory function.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Proton radiotherapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Proton Radiotherapy Experimental Treatment 1 Intervention

Proton Radiotherapy

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

Proton radiotherapy offers a safer treatment option for pediatric cancers by effectively sparing normal tissues, which helps reduce both acute and long-term side effects.

Over the past decade, more than 30 proton therapy facilities have opened in the U.S., allowing approximately 3,000 children annually to access this advanced treatment, with ongoing research to compare its efficacy and toxicity against traditional photon radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of proton therapy in pediatric malignancies: Recent advances and future directions. Greenberger, BA., Yock, TI.[2020]

In a study of 294 pediatric patients treated with proton beam therapy (PBT) for intracranial tumors, the 3-year overall survival rate was 82.7%, indicating promising long-term outcomes for this treatment.

While PBT showed good efficacy, 17 patients experienced grade 3 adverse events, including two cases of vision loss, highlighting the need for careful monitoring of side effects during long-term follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy for Pediatric Tumors of the Central Nervous System-Experiences of Clinical Outcome and Feasibility from the KiProReg Study. Peters, S., Frisch, S., Stock, A., et al.[2022]

Proton beam therapy, while having a better overall side effects profile compared to photon radiation therapy, is associated with a higher incidence of moyamoya syndrome, nearly double that of photon therapy, particularly in pediatric patients.

Children under 5 years old who receive proton beam therapy for brain tumors are at a greater risk of developing moyamoya syndrome, with most diagnoses occurring within the first 2 years after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The incidence of radiation-induced moyamoya among pediatric brain tumor patients who received photon radiation versus those who received proton beam therapy: a systematic review. Elkatatny, A., Ismail, M., Ibrahim, KMM., et al.[2023]

Proton radiation therapy provides similar tumor control as traditional photon radiation therapy for pediatric brain tumors, but with potentially fewer long-term side effects.

The superior physical properties of proton beams make them less likely to cause late effects, offering a safer treatment option for children undergoing radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New technologies in radiation therapy for pediatric brain tumors: the rationale for proton radiation therapy. Kirsch, DG., Tarbell, NJ.[2009]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The role of proton therapy in pediatric malignancies: Recent advances and future directions. [2020]

2. France pubmed.ncbi.nlm.nih.gov

Paediatric brain tumours: A review of radiotherapy, state of the art and challenges for the future regarding protontherapy and carbontherapy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Technology insight: Proton beam radiotherapy for treatment in pediatric brain tumors. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Proton therapy for central nervous system tumors in children. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Incidence and dosimetric parameters of pediatric brainstem toxicity following proton therapy. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy for Pediatric Tumors of the Central Nervous System-Experiences of Clinical Outcome and Feasibility from the KiProReg Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Radiation Necrosis in Pediatric Patients with Brain Tumors Treated with Proton Radiotherapy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Brainstem Injury in Pediatric Patients With Posterior Fossa Tumors Treated With Proton Beam Therapy and Associated Dosimetric Factors. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

The incidence of radiation-induced moyamoya among pediatric brain tumor patients who received photon radiation versus those who received proton beam therapy: a systematic review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Proton therapy for the treatment of children with CNS malignancies. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

New technologies in radiation therapy for pediatric brain tumors: the rationale for proton radiation therapy. [2009]

12. England pubmed.ncbi.nlm.nih.gov

Proton radiotherapy for pediatric tumors: review of first clinical results. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Proton beam irradiation in pediatric oncology: an overview. [2019]