Proton Radiation Therapy for Brain Tumor

Overseen By Tarin Grillo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Pregnancy, Lactation, Uncontrolled illness, 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: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests proton radiation, also known as Proton Beam Therapy or Proton Therapy, as a potential treatment for brain tumors. Proton radiation targets the tumor area more precisely, potentially reducing damage to nearby healthy tissue. The trial is suitable for individuals diagnosed with a brain tumor, such as glioma or meningioma, who require radiation therapy. Participants must understand English and have a life expectancy of at least six months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

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 study team or your doctor.

What prior data suggests that Proton Radiation is safe for treating brain tumors?

Research has shown that proton radiation therapy is safe for treating brain tumors. It targets tumors more precisely than traditional radiation, affecting less of the surrounding healthy tissue and potentially leading to fewer side effects. One study found that proton radiation controlled tumors as effectively as other methods but with fewer risks.

Another study highlighted that proton therapy can limit radiation exposure to non-cancerous areas, reducing the chance of harmful side effects. For those considering joining this trial, these findings suggest that proton radiation is generally well-tolerated. However, discussing specific risks with a doctor is important to understand individual circumstances. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Proton radiation therapy is unique because it targets brain tumors with high precision, minimizing damage to surrounding healthy tissues. Traditional radiation treatments often affect broader areas, which can lead to more side effects. Researchers are excited about proton therapy because it can deliver higher doses directly to the tumor while sparing critical structures, potentially leading to better outcomes and fewer long-term side effects. This precise targeting is particularly important in treating brain tumors, where preserving cognitive and neurological function is crucial.

What evidence suggests that Proton Radiation might be an effective treatment for brain tumors?

Studies have shown promising results for proton radiation therapy in treating brain tumors. Research indicates that patients receiving this therapy achieve excellent long-term survival and tumor control. Proton therapy, which participants in this trial will receive, targets brain tumors more precisely, leading to fewer side effects compared to traditional radiation. Additionally, it has improved cancer control in both the brain and spine. These findings suggest that proton radiation could effectively treat brain tumors. ^{6 7 8 9 10}

Who Is on the Research Team?

Helen A Shih, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Adults over 18 with benign or low-grade brain tumors who need radiation therapy can join this trial. They must be able to understand English, sign consent, use contraception if needed, and have a life expectancy of at least 6 months. People with severe illnesses, heart problems, psychiatric conditions that affect compliance, or pregnant/lactating women cannot participate.

Inclusion Criteria

My diagnosis was made based on scans and symptoms without a biopsy, as it's considered standard care.

I am recommended to undergo proton radiation therapy.

I have a diagnosed brain tumor that needs radiation, such as glioma or meningioma.

Exclusion Criteria

I do not have ongoing infections, heart issues, unstable angina, arrhythmias, or mental health/social situations that would affect my treatment compliance.

Breastfeeding should be discontinued if mother is treated with radiation therapy

I have had cancer before, but it was a different type or treated long ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive Proton Radiation therapy, typically five days per week on weekdays

6-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and quality of life changes after treatment

2 years

Long-term follow-up

Participants are monitored for long-term effects and tumor response up to 5 years post-treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Proton Radiation

Trial Overview

The study is testing Proton Radiation as a treatment for various types of brain tumors including glioma, pituitary adenoma, schwannoma, and meningioma. It's designed to see how well it controls tumor growth while assessing the impact on patients' quality of life and any side effects.

How Is the Trial Designed?

Group I: Proton Radiation Experimental Treatment 1 Intervention

* Radiation therapy will be delivered typically five (5) days per week on weekdays * Proton Radiation dose be determine by histology

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

Approved in United States as Proton Therapy for:

• Brain tumors
• Breast cancer
• Esophageal cancer
• Eye cancer
• Gynecological cancers
• Head and neck cancer
• Liver cancer
• Lung cancer
• Lymphoma
• Pancreatic cancer
• Prostate cancer
• Rectal cancer
• Sarcomas
• Spinal cord tumors

Approved in European Union as Proton Therapy for:

• Similar indications as in the United States, with specific approvals varying by country

Approved in Canada as Proton Therapy for:

• Similar indications as in the United States, with specific approvals varying by province

Approved in Japan as Proton Therapy for:

• Similar indications as in the United States, with specific approvals varying by region

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

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]

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]

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 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]

Proton beam therapy (PBT) has been effectively used for over 50 years, treating more than 60,000 patients worldwide, and utilizes its unique Bragg peak to deliver targeted radiation to tumors while minimizing damage to surrounding healthy tissue.

PBT has shown therapeutic superiority over traditional treatment options for various diseases, particularly since the establishment of dedicated proton therapy facilities, indicating its growing importance in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evidence of particle beam therapy (proton). Ogino, T.[2021]

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]

Proton beam therapy (PBT) is feasible for treating infants with central nervous system tumors, showing promising short-term outcomes with a 3-year overall survival rate of 76.5% among 51 infants studied.

However, the treatment is associated with significant logistical challenges and potential for higher-grade toxicities, including late effects like endocrinopathy and hearing loss, highlighting the need for careful monitoring and longer follow-up to assess long-term impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Proton Beam Therapy for Infants with Brain Tumours: Experiences from the Prospective KiProReg Registry Study. Jazmati, D., Steinmeier, T., Ahamd Khalil, D., et al.[2021]

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) usage in the US increased from 0.4% in 2004 to 1.2% in 2018, particularly among patients with cancers recommended for PBT by the American Society of Radiation Oncology, indicating growing acceptance and application of this treatment.

While PBT use for prostate cancer temporarily decreased from 2011 to 2014, it rebounded by 2018, suggesting fluctuations in treatment preferences or insurance coverage that may influence patient access to this advanced therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Proton Beam Therapy Use Among Patients With Newly Diagnosed Cancer in the US, 2004-2018. Nogueira, LM., Jemal, A., Yabroff, KR., et al.[2022]

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]

NTCP models were successfully developed and validated for predicting scalp erythema and alopecia in 113 adult brain tumor patients treated with proton beam therapy, using dose-volume parameters to guide treatment decisions.

The models showed strong predictive ability with AUC values greater than 0.75 in external validation cohorts, indicating they can help optimize patient quality of life by minimizing these common side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of NTCP models for acute side-effects resulting from proton beam therapy of brain tumours. Dutz, A., Lühr, A., Agolli, L., et al.[2019]

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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.