Proton Radiation for Pediatric Sarcoma

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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to assess the short term and the long term side effects of proton beam radiation for pediatric bone and non-rhabdomyosarcoma soft tissue sarcomas.

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 data supports the effectiveness of the treatment Proton Beam Radiation for pediatric sarcoma?

Proton Beam Radiation is effective for pediatric sarcoma because it targets tumors more precisely, reducing damage to nearby healthy tissues and potentially lowering the risk of side effects. Studies show it is superior to other radiation methods in sparing healthy tissue, and it has been successfully used in treating similar conditions like chondrosarcomas and chordomas. ^{1 2 3 4 5}

Is proton radiation therapy safe for children with cancer?

Proton radiation therapy is generally considered safe for children, as it reduces the risk of damage to healthy tissues and lowers the chances of both immediate and long-term side effects compared to traditional radiation. Studies show that it can limit the risk of late toxicities and secondary cancers, although ongoing research is needed to confirm these benefits over longer periods. ^{1 2 6 7 8}

How is proton beam therapy different from other treatments for pediatric sarcoma?

Proton beam therapy is unique because it targets tumors more precisely, reducing radiation exposure to surrounding healthy tissues, which is especially important in children whose bodies are still growing. This precision helps minimize side effects and long-term complications compared to traditional radiation therapies. ^{1 2 3 9 10}

Research Team

Torunn Yock, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Proton radiotherapy for pediatric sarcoma. [2021]

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

[Proton therapy in soft tissue and bone sarcomas]. [2018]

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

Spot-scanning proton therapy for malignant soft tissue tumors in childhood: First experiences at the Paul Scherrer Institute. [2018]

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

Proton radiotherapy for pediatric Ewing's sarcoma: initial clinical outcomes. [2022]

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

Outcomes following proton therapy for Ewing sarcoma of the cranium and skull base. [2020]

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

The role of proton therapy in pediatric malignancies: Recent advances and future directions. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Long-term follow-up after proton beam therapy for pediatric tumors: a Japanese national survey. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

The Evolving Role of Proton Beam Therapy for Sarcomas. [2022]

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

Proton therapy for sarcomas. [2014]