N/A
N=70
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Non-rhabdomyosarcoma Soft Tissue Sarcoma · Bone Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00592293 ↗Enrolled (actual)
70
Serious AEs
11.6%
Results posted
Jul 2025
Primary outcome: Primary: Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment — 17.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Proton Beam Radiation (Radiation)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2016
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 |
— | — |
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.
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.