Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Study Overview
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Brief Summary
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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.

Detailed Description
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Participants will receive radiation treatments once per day, 5 days a week for a total of 4 to 6 weeks, depending on how much total dose the tumor requires. The radiation doctor will see the participant once each week to monitor and record any side effects they may have from radiation treatment. A special device will be made for each participant to help them hold still during the treatment. This may either be a mask or foam cradle, depending on the area to be treated.

Official Title
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Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Conditions
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Non-rhabdomyosarcoma Soft Tissue Sarcoma, Bone Sarcoma

Intervention / Treatment
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* Radiation: Proton Beam Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy proven NRSTS or bone sarcoma Less than or equal to 30 years of age Patients must have been treated with a standardly accepted chemotherapy regimen if chemotherapy is indicated 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: Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury of collagen vascular disease Patients who are pregnant Previous treatment with radiation therapy Concurrent adriamycin or gemcitabine chemotherapy is planned, unless on a concurrent protocol

Ages Eligible for Study
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Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton Beam Radiation<br>Proton Beam Radiation | Radiation: Proton Beam Radiation<br>* Once per day, 5 days a week for a total of 4 to 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and late toxicities | Assess frequency and severity of morbidities from irradiation using proton beam therapy in this patient population. | 5 years | 
| Local Control | Rates of local control using proton radiotherapy. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetric Comparison | Comparison of Dose distribution to tumor and surrounding normal structures using DVH's generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proton beam radiation