N/A
Completed N=115
Proton Radiation Therapy (RT) for the Treatment of Pediatric Rhabdomyosarcoma
Source: ClinicalTrials.gov NCT00592592 ↗Enrolled (actual)
115
Serious AEs
5.3%
Results posted
Jun 2025
Primary outcomePrimary: Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up — 10.9 Percentage of patients
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Incidence (Estimated Percent of Participants) With Grade 3 or Higher Toxicity in Follow-up |
10.9 | — |
| SECONDARY Percentage of Participants Who Experienced an Acute Toxicity by Grade |
110; 92; 30; 5; 0 | — |
| SECONDARY Dosimetric Comparison |
88; 73; 100; 42 | <0.01 sig |
| SECONDARY Local Control |
80.9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with biopsy proven newly diagnosed rhabdomyosarcoma.
- Patients less than or equal to 30 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.
Data sourced from ClinicalTrials.gov (NCT00592592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.