Proton Radiation for Pediatric Sarcoma

No longer recruiting at 1 trial location

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Adriamycin, Gemcitabine

Disqualifiers: Pregnancy, Previous radiation, 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: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests proton beam radiation to assess its effects on children and young adults with certain sarcomas, which are cancers of the bone and soft tissues. Researchers aim to understand both the short-term and long-term side effects of this treatment. Individuals diagnosed with non-rhabdomyosarcoma soft tissue sarcoma or bone sarcoma who have already received chemotherapy might be suitable candidates. Participants must commit to follow-up care for at least five years. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on adriamycin or gemcitabine chemotherapy, you may need to be on a specific concurrent protocol.

What prior data suggests that proton beam radiation is safe for pediatric sarcoma?

Research shows that proton beam radiation is generally safe for children with cancer. Studies have found it causes fewer long-term side effects than traditional radiation, such as a lower chance of developing new cancers later. Proton therapy targets tumors more precisely, causing less harm to healthy tissue.

Other research suggests that children receiving proton therapy often have better survival rates than those receiving standard radiation. Proton beam therapy is linked to fewer short-term and long-term harmful effects, meaning children are less likely to experience negative effects during and after treatment.

In summary, current evidence supports proton beam radiation as a safe option for treating pediatric sarcoma, with fewer side effects compared to conventional radiation methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Proton Beam Radiation is unique because it targets tumors with high precision, minimizing damage to surrounding healthy tissue. Unlike traditional X-ray radiation, which passes through the body and can affect both the tumor and nearby areas, proton therapy delivers radiation directly to the tumor site. This precision reduces side effects and is particularly beneficial for pediatric patients whose developing tissues are more sensitive to radiation. Researchers are excited about this treatment because it offers the potential for more effective and safer cancer therapy for children with sarcoma.

What evidence suggests that proton beam radiation might be an effective treatment for pediatric sarcoma?

Research has shown that proton beam radiation, the treatment under study in this trial, can effectively treat pediatric sarcomas. One study found that children who received proton beam therapy had better survival rates than those who received traditional photon radiation therapy. Specifically, 79% of children treated with proton therapy survived for three and five years. Proton therapy is preferred because it targets tumors more precisely, causing less harm to nearby healthy tissues. This precision is especially important for children, as it can lead to fewer side effects. Overall, proton beam radiation appears to be a safer and effective option for treating pediatric sarcomas. ^{2 4 6 7 8}

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 up to 30 years old with bone sarcoma or non-rhabdomyosarcoma soft tissue sarcomas. They must have had standard chemotherapy if needed, agree to long-term follow-up at MGH, and provide informed consent. Pregnant individuals, those planning certain chemotherapies, or with conditions making radiation unsafe are excluded.

Inclusion Criteria

Patients must be willing to receive follow-up care for a minimum of five years after treatment at MGH and annual visits unless it is too difficult to return to MGH for follow-up care. In that event, the patient or guardian must be willing to have their outside medical information released in order to track the results of treatment

They or their legal guardian must give their informed consent

Timing of radiation may be according to concurrent protocol

Exclusion Criteria

I have health conditions that make radiation unsafe for me.

I have undergone radiation therapy before.

I am planned to receive adriamycin or gemcitabine chemotherapy, unless I am on another specific treatment protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive proton beam radiation treatments once per day, 5 days a week for a total of 4 to 6 weeks

4-6 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, assessing acute and late toxicities

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Proton Beam Radiation

Trial Overview

The study is examining the effects of proton beam radiation therapy on pediatric patients with specific types of sarcomas. It aims to understand both immediate and long-term side effects from this treatment over a minimum five-year follow-up period.

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+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

Proton beam radiotherapy offers significant advantages over standard photon radiation for treating pediatric sarcomas by minimizing radiation exposure to surrounding healthy tissues, which is crucial given the proximity of these tumors to critical structures and growing organs.

Emerging data suggests that proton therapy not only improves dosimetric outcomes compared to traditional radiation methods like IMRT and 3D conformal radiation but also shows promising long-term clinical outcomes and reduced toxicity in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton radiotherapy for pediatric sarcoma. Ladra, MM., Yock, TI.[2021]

Proton therapy is preferred for treating pediatric sarcomas because it effectively spares healthy tissue, reducing potential damage compared to traditional photon therapies.

This treatment has a proven track record in managing specific types of tumors, like chondrosarcomas and chordomas, and ongoing clinical trials are evaluating its effectiveness in various sarcoma cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Proton therapy in soft tissue and bone sarcomas]. Thariat, J., Tessonnier, T., Bonvalot, S., et al.[2018]

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]

Proton beam therapy may lead to fewer side effects compared to conventional photon therapy, particularly in children with brain tumors and certain adult cancers, while showing similar overall survival rates.

The estimated cost of establishing a proton beam therapy center in Ontario is $124.8 million over five years, but it could significantly reduce per-patient costs compared to current out-of-country treatments, making it a potentially cost-effective option for specific pediatric cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy for Cancer in Children and Adults: A Health Technology Assessment. [2022]

Proton beam therapy offers a significant dosimetric advantage over traditional x-ray radiation therapy by reducing radiation exposure to healthy tissues, which could enhance treatment outcomes for sarcomas.

This therapy may improve the therapeutic ratio by either increasing the dose to the tumor for better local control or decreasing complications in surrounding normal tissues, making it a promising option for sarcoma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton therapy for sarcomas. Keole, S., Ashman, JB., Daniels, TB.[2014]

Citations

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pmc.ncbi.nlm.nih.gov

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Proton radiation markedly decreased dose to the brain, temporal lobes, hypothalamic-pituitary axis, and both the ipsilateral and contralateral ...

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frontiersin.org

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Proton beam radiation therapy vs. photon ...

Patients who received PBT had better median OS compared to those who received photon RT. The three and five- year survival rates were 79% (95% ...

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sciencedirect.com

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Proton beam therapy in paediatric radiation oncology

Proton Beam Therapy (PBT) is an increasingly utilised modality for treating tumours by utilising the physical properties of accelerated proton beams.

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advancesradonc.org

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The Pediatric Proton and Photon Therapy Comparison ...

Proton therapy has emerged as a preferred radiation therapy modality for some cancers because the physical properties of protons lower doses to ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12488416/

Proton beam radiation therapy vs. photon ... - PubMed Central

The one, two, three, four, and five-year survival rates of 95%, 85%, 78%, 73%, and 71% of rhabdomyosarcoma patients in our study are also ...

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pmc.ncbi.nlm.nih.gov

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Paediatric proton therapy - PMC - PubMed Central - NIH

Furthermore, the use of protons in CSI reduced the estimated risk of secondary cancer compared to conventional photons as revealed by comparative dose studies ...

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Proton beam therapy for pediatric cancers

Proton beam therapy is transforming pediatric cancer care, with improved outcomes and reduced long-term side effects.

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Efficacy and safety of proton beam therapy for ...

The data showed that PBT is a feasible, safe, and effective modality for RMS, showing promising LC, OS, PFS, and lower acute and late toxicities.