N/A
N=14
Stereotactic Radiation Therapy for Pediatric Sarcomas
Sarcoma · Metastatic Disease · Bony Sites
Bottom Line
View on ClinicalTrials.gov: NCT01763970 ↗Enrolled (actual)
14
Serious AEs
14.3%
Results posted
Aug 2020
Primary outcome: Primary: Lesion-specific Local Control at 6 Months Post-SBRT as Assessed by Percentage of Lesions Locally Controlled — 95 percentage of lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SBRT (Radiation)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lesion-specific Local Control at 6 Months Post-SBRT as Assessed by Percentage of Lesions Locally Controlled |
95 | — |
| SECONDARY Patient-specific Local Control at 6 Months Post-SBRT as Assessed by the Percentage of Patients Locally Controlled |
89 | — |
| SECONDARY Percentage of Patients With Progression-free Survival at 6 Months Post-SBRT |
50 | — |
| SECONDARY Percentage of Patients With Overall Survival at 6 Months Post-SBRT |
100 | — |
| SECONDARY Change in Quality of Life (QoL) as Assessed by the Brief Pain Inventory |
2; 2.1 | — |
| SECONDARY Number of Participants Experiencing Toxicity of SBRT |
9 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01763970). 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.