Proton Beam Radiation for Brain Tumor

Recruiting at 1 trial location

Overseen By Shannon MacDonald, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Chemotherapy

Disqualifiers: Prior radiation, Different malignancy, 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: Unknown

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow the use of Vincristine alongside the treatment.

What data supports the effectiveness of the treatment Proton Beam Therapy for brain tumors?

Proton Beam Therapy is promising for brain tumors as it can minimize damage to surrounding healthy tissues and reduce the risk of secondary cancers, especially in pediatric cases. It is considered superior to traditional radiation in certain brain and skull-base tumors, with studies showing it helps maintain cognitive function and quality of life. ^{1 2 3 4 5}

Is proton beam therapy safe for humans?

Proton beam therapy (PBT) has been used in over 60,000 patients worldwide and is considered safe for treating various conditions, including brain tumors and prostate cancer. Studies have shown that PBT can help reduce side effects compared to traditional radiation therapy by sparing surrounding healthy tissues, although some side effects may still occur. ^{2 5 6 7 8}

How is proton beam therapy different from other treatments for brain tumors?

Proton beam therapy is unique because it uses positively charged particles (protons) that allow for precise targeting of tumors, minimizing damage to surrounding healthy tissues. This makes it especially beneficial for treating brain tumors located near sensitive areas, reducing the risk of side effects like neurocognitive decline and secondary cancers compared to traditional radiation therapy. ^{1 2 9 10 11}

What is the purpose of this trial?

This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation. The radiation involved in this study is: -Proton Radiation

Research Team

Shannon MacDonald, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for children and teenagers aged 3 to 18 with certain types of brain tumors that need radiation treatment. They should have a life expectancy of at least one year, adequate blood counts, and no prior high-dose radiation therapy. Pregnant teens or those who could become pregnant must not be sexually active or must test negative for pregnancy.

Inclusion Criteria

I have a cancer diagnosis that requires radiation to the brain and spine.

Signed informed consent document and assent when appropriate

Your hemoglobin level is higher than 10 grams per liter and your platelet count is greater than 80,000 per microliter.

Exclusion Criteria

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

I have received radiation therapy of more than 500 cGy.

I am receiving chemotherapy, but not Vincristine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive proton beam radiation therapy once daily, 5 days per week, with a focus on sparing the bony spine

6-8 weeks

Daily visits (in-person) for radiation treatment

Follow-up

Participants are monitored for safety, effectiveness, and changes in growth and development after radiation treatment

5 years

Annual visits (in-person) for evaluations and imaging

Treatment Details

Interventions

• Proton Beam

Trial Overview The study is testing proton beam radiation as a potential treatment option for pediatric brain tumors. Proton radiation aims to target the tumor while sparing healthy bone tissue, potentially reducing growth issues caused by traditional radiation treatments.

Participant Groups

Group I: Proton Radiotherapy Experimental Treatment 1 Intervention

* Patients will be treated with Proton Beam once daily 5 days per week. * Doses will be prescribed such that maximum possible coverage is achieved

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

Approved in European Union as Proton Therapy for:

• Brain tumors
• Spinal tumors
• Pediatric cancers
• Eye tumors
• Prostate cancer
• Breast cancer
• Lung cancer
• Liver cancer

Approved in United States as Proton Beam Therapy for:

• Brain tumors
• Spinal tumors
• Pediatric cancers
• Eye tumors
• Prostate cancer
• Breast cancer
• Lung cancer
• Liver cancer

Approved in Japan as Proton Therapy for:

• Brain tumors
• Spinal tumors
• Pediatric cancers
• Eye tumors
• Prostate cancer
• Breast cancer
• Lung cancer
• Liver cancer

Approved in Canada as Proton Therapy for:

• Brain tumors
• Spinal tumors
• Pediatric cancers
• Eye tumors
• Prostate cancer
• Breast cancer
• Lung cancer
• Liver cancer

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+

Findings from Research

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 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 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) 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]

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]

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]

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]

Proton and light ion therapies show promise in treating brain tumors due to their unique physical properties, which may allow for more effective tumor destruction while minimizing damage to surrounding healthy nervous tissue.

The review highlights the need for further neuropathological studies to fully understand the mechanisms and potential benefits of these new radiation modalities compared to traditional photon therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy by particle beams (hadrontherapy) of intracranial tumours: a survey on pathology. Schiffer, D.[2019]

Proton minibeam radiation therapy (pMBRT) demonstrated significant tumor control and eradication in 22% of glioma-bearing rats, indicating its potential effectiveness against high-grade gliomas.

pMBRT showed a remarkable reduction in neurotoxicity compared to standard proton therapy, allowing for the irradiation of large brain areas without substantial damage, thus widening the therapeutic window for treating infiltrative gliomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton minibeam radiation therapy widens the therapeutic index for high-grade gliomas. Prezado, Y., Jouvion, G., Patriarca, A., et al.[2023]

References

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

Proton Radiotherapy for Skull-Base Malignancies: Imaging Considerations of Radiotherapy and Complications. [2023]

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

[Is proton beam therapy the future of radiotherapy? Part I: clinical aspects]. [2018]

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

Individual patient information to select patients for different radiation techniques. [2017]

4. Ireland pubmed.ncbi.nlm.nih.gov

An evidence based review of proton beam therapy: the report of ASTRO's emerging technology committee. [2018]

5. England 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. [2022]

6. United States 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. [2022]

7. England 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. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Development and validation of NTCP models for acute side-effects resulting from proton beam therapy of brain tumours. [2019]

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

Assessment of Proton Beam Therapy Use Among Patients With Newly Diagnosed Cancer in the US, 2004-2018. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Radiotherapy by particle beams (hadrontherapy) of intracranial tumours: a survey on pathology. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Proton minibeam radiation therapy widens the therapeutic index for high-grade gliomas. [2023]