Sarcoma,Soft Tissue Clinical Trial
Official title:
Pilot Study Evaluating Stereotactic Body Radiation Therapy (SBRT) and Adaptive Radiation Therapy (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
Verified date | January 2023 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | October 4, 2019 |
Est. primary completion date | October 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Froedtert Hospital and Medical College of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of Life Questionnaire Score | 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, 6 months, 12 months, 18 months, 24 months, and 36 months | |
Other | Overall Survival | This measure is the number of subjects alive at three years. | 3 years | |
Primary | Number of Adverse Events of Grade = 3 by CTCAE Criteria. | 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. | 6 weeks post SBRT | |
Secondary | Number of Subjects Experiencing Locoregional Recurrences. | 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. | 3 years |
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