Clinical trial · Interventional
Stereotactic Radiation Therapy for Pediatric Sarcomas
A Phase II Study of Hyperfractionated Stereotactic Radiotherapy in the Treatment of Metastatic Pediatric Sarcomas of Bony Sites
- 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 stereotactic body radiation therapy (SBRT) literature focuses on clinical outcomes in the adult population. However, SBRT has a particularly strong rationale for application in pediatrics given that high biologically effective doses have been shown to increase control in histologies, such as sarcoma, which are common in the pediatrics population. With stereotactic radiation therapy techniques, a reduction in normal tissue dose surrounding the target lesion of interest may also be accomplished resulting in lower toxicity. Given that pediatric patients with sarcomas, presenting with limited metastases in lung and bone, are still considered to be a curable population with aggressive local therapy, SBRT could have a significant impact on outcomes in oligometastatic patients who may be otherwise unresectable.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bony Sites | — | UNRESOLVED | — |
| Metastatic Disease | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated SBRT
- description
- 800 cGy delivered in 5 fractions every day to total dose of 4000 cGy
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
- measure
- Lesion-specific Local Control at 6 Months Post-SBRT as Assessed by Percentage of Lesions Locally Controlled
- timeFrame
- 6 months post-SBRT
- description
- Local control was defined as the absence of local progression. Local progression was defined as: * (1) the development of a new soft tissue mass ≥1 cm at a site without a soft tissue component or with a soft tissue component \<1 cm in at baseline * (2) an increase in the largest axial dimension of the soft tissue component by \>20% in lesions with a ≥ 1 cm in soft tissue component at baseline * (3) a previous bone metastasis that was avid on fluorodeoxyglucose (FDG)-positron emission tomography (PET), became non-avid after SBRT, and then became avid again. The Kaplan-Meier method was used.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically confirmed metastatic sarcoma of the soft tissue or bone * must have measurable disease * disease must be surgically unresectable as determined by a tumor board or surgeon * greater than 3 years of age * less than or equal to 40 years of age * life expectancy of at least 9 months * adequate performance status (Lansky Performance Status greater than or equal to 50). * ability to understand and willingness to sign informed consent document Exclusion Criteria: * patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study * patients who have had any prior radiotherapy to the treatment site(s) * patients may not participate on any other treatment protocol while they are receiving treatment on this protocol and for up to 3 months after these protocol treatments have ended * pregnant women * refusal of women of child bearing potential to take a pregnancy test prior to treatment
References
Publications (0)
Data not yet available