N/A
Completed N=70
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Non-rhabdomyosarcoma Soft Tissue Sarcoma · Bone Sarcoma
Source: ClinicalTrials.gov NCT00592293 ↗
Enrolled (actual)
70
Serious AEs
11.6%
Results posted
Jul 2025
Primary outcomePrimary: Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment — 17.7 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment |
17.7 | — |
| PRIMARY Local Control |
87.1 | — |
| SECONDARY Dosimetric Comparison |
— | — |
Eligibility Criteria
Inclusion Criteria
- Biopsy proven Non-Rhabdomyosarcoma Soft Tissue Sarcoma (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
Data sourced from ClinicalTrials.gov (NCT00592293). 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.