100 Participants Needed

Proton Radiation Therapy for Brain Tumor

TG
Overseen ByTarin Grillo
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This research study is studying Proton Radiation as a possible treatment for brain tumor. The radiation involved in this study is: -Proton 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 study team or your doctor.

What data supports the effectiveness of the treatment Proton Radiation Therapy for Brain Tumor?

Proton radiation therapy is shown to be effective in treating brain tumors by minimizing damage to surrounding healthy tissues, which can help reduce side effects and improve quality of life. Studies have demonstrated its benefits in reducing neurocognitive decline and the risk of secondary cancers compared to traditional radiation methods.12345

Is proton radiation therapy generally safe for humans?

Proton radiation therapy has been studied for various conditions, including brain and prostate cancer, and is generally considered safe. Research shows it may reduce side effects compared to traditional radiation, especially in younger patients, while maintaining treatment effectiveness.36789

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

Proton radiation therapy is unique because it uses protons to deliver radiation directly to the tumor, minimizing damage to surrounding healthy tissues. This precision reduces the risk of side effects like neurocognitive decline and secondary cancers, making it especially beneficial for treating brain tumors near sensitive areas.24101112

Research Team

Member Detail - DF/HCC

Helen A Shih, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.
See 7 more

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.
See 2 more

Timeline

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

Treatment Details

Interventions

  • Proton Radiation
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Proton RadiationExperimental Treatment1 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:

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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
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Approved in European Union as Proton Therapy for:
  • Similar indications as in the United States, with specific approvals varying by country
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Approved in Canada as Proton Therapy for:
  • Similar indications as in the United States, with specific approvals varying by province
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Approved in Japan as Proton Therapy for:
  • Similar indications as in the United States, with specific approvals varying by region

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Findings from Research

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.
[Proton beam therapy: clinical indications and summary of the Swiss experience].Weber, DC., Mirimanoff, RO., Miralbell, R.[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.
Proton Radiotherapy for Skull-Base Malignancies: Imaging Considerations of Radiotherapy and Complications.Holtzman, AL., Dagan, R., Mendenhall, WM.[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.
Health-related quality of life in patients with primary brain tumors during and three months after treatment with proton beam therapy.LangegΓ₯rd, U., Fransson, P., Bjork-Eriksson, T., et al.[2022]

References

[Proton beam therapy: clinical indications and summary of the Swiss experience]. [2018]
Proton Radiotherapy for Skull-Base Malignancies: Imaging Considerations of Radiotherapy and Complications. [2023]
Health-related quality of life in patients with primary brain tumors during and three months after treatment with proton beam therapy. [2022]
[Is proton beam therapy the future of radiotherapy? Part I: clinical aspects]. [2018]
Individual patient information to select patients for different radiation techniques. [2017]
Multi-institutional Phase II study of proton beam therapy for organ-confined prostate cancer focusing on the incidence of late rectal toxicities. [2022]
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]
Development and validation of NTCP models for acute side-effects resulting from proton beam therapy of brain tumours. [2019]
Proton Therapy in the Adolescent and Young Adult Population. [2023]
Feasibility of Proton Beam Therapy for Infants with Brain Tumours: Experiences from the Prospective KiProReg Registry Study. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Assessment of Proton Beam Therapy Use Among Patients With Newly Diagnosed Cancer in the US, 2004-2018. [2022]
Clinical evidence of particle beam therapy (proton). [2021]