18 and older, any sex, with Stage IV Adult Soft Tissue Sarcoma or Sarcoma,Soft Tissue. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria.Primary· 6 weeks post SBRT
This measure (number of adverse events of grade ≥ 3 by Common Terminology Criteria for Adverse Events (CTCAE) criteria) will provide information regarding the acute toxicity of SBRT for \< 5 pulmonary metastases from soft tissue sarcoma..The CTCAE criteria provide a standardized description of adverse events including guidelines for grading severity. The guidelines can be viewed at: https://ctep.cancer.gov/protocoldevelopment/electronic\_applications/ctc.htm.
Group
Value
95% CI
Stereotactic Body Radiation Therapy
8
Number of Subjects Experiencing Locoregional Recurrences.Secondary· 3 years
This measure (number of subjects experiencing locoregional recurrences) will provide information regarding locoregional control. Locoregional recurrence means any new or renewed tumor growth of any size observed by an imaging technology that is located at or adjacent to a prior treatment site.
Group
Value
95% CI
Stereotactic Body Radiation Therapy
0
Quality of Life Questionnaire ScoreSecondary· Baseline, 6 months, 12 months, 18 months, 24 months, and 36 months
Quality of life will be measured using the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. The FACT-L is a statistically validated, 36-question, Likert-type instrument using a five-point scale from 0 (not at all) to 4 (very much). The questionnaire assesses 5 domains: physical, social/family, emotional, and functional well-being; and lung cancer subscale (symptoms, cognitive function, regret of smoking). The subscale scores are added to determine the total score. The scoring range is 0-28 with higher numbers indicating more severe outcomes.
Baseline
Group
Value
95% CI
Stereotactic Body Radiation Therapy
17.1
± 1.5
6 Months
Group
Value
95% CI
Stereotactic Body Radiation Therapy
16.7
± 3.2
12 Months
Group
Value
95% CI
Stereotactic Body Radiation Therapy
16.3
± 1.9
18 Months
Group
Value
95% CI
Stereotactic Body Radiation Therapy
16.4
± 1.5
24 Months
Group
Value
95% CI
Stereotactic Body Radiation Therapy
17.0
± 1.5
36 Months
Group
Value
95% CI
Stereotactic Body Radiation Therapy
17.1
± 1.1
Overall SurvivalSecondary· 3 years
This measure is the number of subjects alive at three years.
Group
Value
95% CI
Stereotactic Body Radiation Therapy
5
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
Last refreshed: 28 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01949506.