Proton Beam Radiotherapy for Brain Cancer

No longer recruiting at 1 trial location

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Prior radiation, Recurrent disease, Pregnancy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests proton beam radiation for treating brain cancer, specifically medulloblastoma or pineoblastoma. Proton beam radiation targets the tumor more precisely, potentially causing less harm to surrounding healthy tissue compared to traditional photon radiation. The study focuses on delivering radiation to the entire central nervous system, a process called craniospinal irradiation. Suitable participants have had a recent diagnosis, biopsy, or surgery for medulloblastoma or pineoblastoma and have not received prior radiation therapy. As an unphased trial, this study offers a unique opportunity to advance treatment options for brain cancer.

Do I need to stop my current medications for this trial?

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 is safe for craniospinal irradiation?

Research has shown that proton beam radiation is generally safe and well-tolerated for treating brain tumors. It precisely targets tumor cells, helping to protect healthy brain tissue. As a result, there are usually fewer side effects compared to traditional radiation. Studies have found that proton therapy effectively controls tumors while minimizing harm to normal tissue. An early review confirmed that proton therapy is safe and can deliver targeted treatment without causing excessive side effects. This makes proton beam radiation a promising option for treating brain cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Proton Beam Radiation is unique because it targets brain cancer cells with high precision, minimizing damage to surrounding healthy tissues. Unlike traditional radiation therapy, which can affect a broader area, proton therapy uses charged particles that can be more accurately controlled. This precise delivery reduces side effects and may improve the quality of life for patients. Researchers are excited about this treatment because it offers the potential for more effective cancer control with fewer adverse effects compared to conventional options like X-ray radiation therapy.

What evidence suggests that proton beam radiation is effective for brain cancer?

Research has shown that proton beam radiation therapy, which participants in this trial will receive, effectively targets brain tumors while causing less damage to nearby healthy tissue compared to traditional radiation. Studies have found that it significantly reduces the risk of neurocognitive decline, helping to maintain brain function. It also enhances patients' quality of life by reducing long-term side effects. Proton therapy uses high-energy beams to precisely destroy the DNA of tumor cells, stopping them from growing. Although the number of patients studied continues to increase, the results so far are promising for those with brain cancer. ^{1 2 3 6 7}

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 individuals aged 3-25 with a confirmed diagnosis of medulloblastoma or pineoblastoma, who have had surgery but no prior chemotherapy or radiation. They must start treatment within 35 days post-surgery and have a life expectancy over 3 months. Participants need adequate blood lab values and agree to use contraception.

Inclusion Criteria

Life expectancy of greater than 3 months

Blood laboratory values as outlined in the protocol

I have had a biopsy or surgery confirming I have medulloblastoma or pineoblastoma.

Exclusion Criteria

I have undergone more than one chemotherapy treatment.

I have had radiation therapy before.

Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Radiation

Participants receive proton beam radiation therapy to the CNS, 5 days a week for approximately 6 weeks

6 weeks

30 visits (in-person)

Follow-up

Participants are monitored for neurocognitive, neuroendocrine, and ototoxicity outcomes after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Proton Beam Radiation

Trial Overview The study is examining proton beam radiation therapy as an alternative to the traditional photon beam therapy for brain tumors. It aims to see if proton beams can effectively target the tumor while sparing more healthy tissue due to its precise delivery method.

How Is the Trial Designed?

Group I: Proton Beam Radiation Experimental Treatment 1 Intervention

Proton Beam Radiation

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

Approved in European Union as Proton Therapy for:

• Cancer of the brain and spinal cord
• Eye melanoma
• Head and neck cancers
• Breast cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer

Approved in United States as Proton Beam Therapy for:

• Brain tumors
• Eye melanoma
• Head and neck cancers
• Breast cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer
• Pediatric cancers

Approved in Japan as Proton Radiotherapy for:

• Brain tumors
• Eye melanoma
• Head and neck cancers
• Breast cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer

Approved in Canada as Proton Therapy for:

• Brain tumors
• Eye melanoma
• Head and neck cancers
• Breast cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Prostate cancer

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 151 patients with organ-confined prostate cancer, proton beam therapy (PBT) demonstrated a low incidence of late Grade 2 or greater rectal toxicities, reported at only 2.0% after 2 years of follow-up.

The study indicates that PBT is a safe treatment option for localized prostate cancer, with minimal acute and late toxicities, suggesting it can effectively control side effects while delivering targeted radiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional Phase II study of proton beam therapy for organ-confined prostate cancer focusing on the incidence of late rectal toxicities. Nihei, K., Ogino, T., Onozawa, M., et al.[2022]

Proton therapy may offer significant advantages over traditional photon therapy for certain head and neck cancer patients, as it delivers similar doses to tumors while reducing exposure to surrounding healthy tissues.

A simulation model developed from data of 1013 patients can help identify which individuals are likely to benefit most from proton therapy, particularly those with a good prognosis and high risk of damage to adjacent organs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual patient information to select patients for different radiation techniques. Quik, EH., Feenstra, TL., Postmus, D., et al.[2017]

In a study of 192 prostate cancer patients treated with proton beam therapy (PBT) over a median follow-up of 1.7 years, only 5 patients experienced grade 3 toxicity, with no occurrences of grade 4 or 5 toxicity, indicating a high safety profile for this treatment.

Patient-reported outcomes showed stable urinary function post-treatment, while sexual health scores declined slightly at 1 year but did not worsen thereafter; bowel function scores also decreased but stabilized, suggesting manageable side effects associated with PBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early toxicity and patient reported quality-of-life in patients receiving proton therapy for localized prostate cancer: a single institutional review of prospectively recorded outcomes. Lee, HJ., Macomber, MW., Spraker, MB., et al.[2019]

Proton beam therapy offers a more precise radiation dose distribution compared to conventional radiotherapy, resulting in less damage to surrounding healthy tissues and a lower incidence of treatment-related side effects.

Clinical evidence suggests that proton beam therapy has improved outcomes for specific cancers, such as uveal melanoma, skull-base or spinal sarcomas, and prostate cancer, but further extensive studies are needed to explore its benefits across more types of cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Proton beam therapy: clinical indications and summary of the Swiss experience]. Weber, DC., Mirimanoff, RO., Miralbell, R.[2018]

Proton beam therapy (PBT) shows potential benefits for treating certain cancers, such as pediatric CNS tumors and large ocular melanomas, but current evidence does not support its superiority over traditional photon-based therapies for most other cancer types.

The American Society of Radiation Oncology (ASTRO) recommends further robust clinical trials to better define the appropriate use of PBT, as existing data is insufficient to endorse its routine application in many malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence based review of proton beam therapy: the report of ASTRO's emerging technology committee. Allen, AM., Pawlicki, T., Dong, L., et al.[2018]

In a study of 266 adult patients with primary brain tumors treated with proton beam therapy (PBT), significant declines in health-related quality of life (HRQoL) were observed, particularly in physical and cognitive functioning, three months post-treatment.

Fatigue and depression were the most common symptoms reported, highlighting the need for effective symptom management strategies and evidence-based guidelines to improve HRQoL for patients undergoing PBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life in patients with primary brain tumors during and three months after treatment with proton beam therapy. Langegård, U., Fransson, P., Bjork-Eriksson, T., et al.[2022]

Proton beam radiation therapy may be beneficial for adolescent and young adult cancer patients by potentially reducing radiation exposure to healthy tissues, which could lower the risk of side effects after treatment.

Current literature suggests that proton therapy is effective for treating specific cancers like central nervous system tumors and Hodgkin lymphoma, but further research is needed to fully establish its role and benefits in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Therapy in the Adolescent and Young Adult Population. Ahmed, SK., Keole, SR.[2023]

Proton beam therapy is recognized for its superior dose-distribution capabilities, particularly beneficial for treating deep-seated tumors near critical structures, making it the 'gold standard' for specific adult cancers like ocular melanoma and chordoma.

With over 60,000 patients treated globally, proton beam therapy is also being explored for pediatric cancers and other malignancies, showing promise in reducing side effects compared to conventional radiation therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Is proton beam therapy the future of radiotherapy? Part I: clinical aspects]. Bouyon-Monteau, A., Habrand, JL., Datchary, J., et al.[2018]

Proton therapy (PT) is an effective radiotherapy option for treating both benign and malignant brain conditions, showing promise in reducing neurocognitive decline and the risk of second cancers.

PT has low rates of central nervous system necrosis, making it a safer alternative compared to traditional radiotherapy methods, with potential for further improvements through biological optimization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Radiotherapy for Skull-Base Malignancies: Imaging Considerations of Radiotherapy and Complications. Holtzman, AL., Dagan, R., Mendenhall, WM.[2023]

Citations

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

Proton therapy for brain tumours in the area of evidence ... Reported results however regarding long-term toxicities from clinical proton studies show encouraging results, although the patient numbers are small. More ...

2. 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 ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00132

Proton Therapy: Current Status and Controversies Proton therapy is categorically an exciting technology with considerable potential to improve outcomes and widen the therapeutic ratio for patients with cancer.

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)04601-8/fulltext

Prospective clinical trial of upright image-guided proton ... Conclusion. This interim analysis shows that chair-based, upright, image-guided, adaptive proton therapy is a feasible, safe, and dosimetrically ...

5. hopkinsmedicine.org hopkinsmedicine.org/health/conditions-and-diseases/brain-tumor/proton-therapy

Proton Therapy for Brain Tumors Proton therapy is a high-energy beam that precisely targets tumor cells in the brain to destroy their DNA.

6. academic.oup.com academic.oup.com/nop/article/11/4/369/7659617

Controversies in neuro-oncology: Focal proton versus photon ... Several studies have demonstrated that proton therapy (PT) provides a reduced dose to healthy brain parenchyma compared with photon-based (xRT) radiation ...

7. 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 ...