Clinical trial · Interventional
Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
NCT00592293CI-TRIAL-00091725completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Sarcoma | Bone Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Non-rhabdomyosarcoma Soft Tissue Sarcoma | Soft Tissue Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Beam Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Beam Radiation
- description
- Proton Beam Radiation
- interventionNames
- Radiation: Proton Beam Radiation
Primary outcomes (2)
- measure
- Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment
- timeFrame
- 5 years from the completion of radiation treatment
- description
- Cumulative incidence (percent of participants and 95% confidence intervals) who experienced a grade 3, 4, or 5 late toxicity. Late complications are defined as the delayed effects attributable to radiation which occur \> 90 days following completion of radiation.
- measure
- Local Control
- timeFrame
- 5 years from the start of radiation treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.