N/A
N=9
(SBRT) and (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
Stage IV Adult Soft Tissue Sarcoma · Sarcoma,Soft Tissue
Bottom Line
View on ClinicalTrials.gov: NCT01949506 ↗Enrolled (actual)
9
Serious AEs
37.5%
Results posted
Feb 2023
Primary outcome: Primary: Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria. — 8 events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SBRT (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria. |
8 | — |
| SECONDARY Number of Subjects Experiencing Locoregional Recurrences. |
— | — |
Summary
This is a prospective study to document the local control rates with SBRT specifically for pulmonary metastases from soft tissue sarcoma. This study will prospectively document acute and late toxicity, quality of life (QoL), tumor control, and survival.
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age
- Pathologic confirmation of primary soft tissue sarcoma with pathologic or radiographic evidence of pulmonary metastatic disease
- No evidence of extra pulmonary progression of disease for 3 months prior to enrollment on study
- 1-5 pulmonary lesions all ≤5 cm in size
- Medically inoperable or declines surgery
- Patients may have had previous treatment for pulmonary metastases
Exclusion Criteria
- Patients who have uncontrolled extra-pulmonary disease
- Pregnant women
- Patients who have greater than 5 pulmonary lesions at the time of study enrollment
- Patients who have disease progression outside the lungs within 3 months of enrollment on the study
- Disease pathology other than sarcoma subtypes
- Patients with a history of metastatic disease from a primary other than sarcoma
Data sourced from ClinicalTrials.gov (NCT01949506). 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.