Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Study Overview
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Brief Summary
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The main purpose of this study is to see if using proton beam radiation therapy instead of photon beam radiation therapy can reduce side effects from radiation treatment for rhabdomyosarcoma. Photon beam radiation is the standard type of radiation for treating most rhabdomyosarcoma and many other types of cancer. Photon beam radiation enters the body and passes through healthy tissue, encounters the tumor, then leaves the body through healthy tissue. A beam of proton radiation enters the body and passes through healthy tissue, encounters tumor, but then stops. This means that less healthy tissue is affected by proton beam radiation than by photon beam radiation.

Detailed Description
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A special device is made for each participant to help them hold still during the treatment. This may be in the form of a mask or a custom made foam cradle depending on the area to be treated. Radiation treatments will be given once per day, 5 days a week for a total of 4 to 6 weeks, depending upon how much total dose the tumor requires. Participants will be seen once per week by their radiation doctor to monitor health and record any side effects from treatment. After the radiation treatments are completed, participants will be required to undergo further tests and evaluations for several years following treatment.

Official Title
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A Phase II Trial of Proton RT for the Treatment of Pediatric Rhabdomyosarcoma

Conditions
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Rhabdomyosarcoma

Intervention / Treatment
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* Radiation: Proton Beam Radiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with biopsy proven newly diagnosed rhabdomyosarcoma. Patients less than or equal to 21 years of age. Patients must be treated with a standardly accepted chemotherapy regimen. May not have metastatic disease unless aged 2-10 with embryonal histology. 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, they must be willing to have their outside medical information released to us to track the results. Timing of radiation must be according to the IRB protocol upon which the patient is treated within either 35 days of last chemotherapy or surgery. Exclusion Criteria: Life expectancy of less than 2 years. Co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease. Patients who are pregnant Previous treatment with radiation therapy.

Ages Eligible for Study
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Maximum Age: 21 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 |
| --- | --- | --- |
| Late toxicity | Frequency and severity of late complications from irradiation using proton beam therapy in place of conventional photon beam therapy in pediatric patients with pediatric rhabdomyosarcomas. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity | Frequency and severity of acute side effects from irradiation using proton beam therapy in this patient population. | 4 years | 
| 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. | 4 years | 
| Local Control | Rates of local control using proton radiotherapy. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric rhabdomyosarcoma, proton radiation therapy