An interventional study of SBRT in Stage IV Adult Soft Tissue Sarcoma and Sarcoma,Soft Tissue, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
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.
A total of no more than 20 people are expected to participate in this study at the Medical College of Wisconsin/Froedtert Hospital. Patients will be followed for three years.
The usual treatment for sarcomas that spread to the lungs is to remove the cancer with surgery. Patients who cannot have surgery or prefer not to have surgery, can receive radiation therapy. Standard radiation therapy involves several weeks of daily treatment sessions, although it is not as effective as surgery and may seriously damage normal surrounding lung tissue. Stereotactic body radiation therapy (SBRT) is a radiation treatment that gives fewer but higher doses of radiation than standard radiation. SBRT is used to treat metastases to the lung from many types of cancer but has not been used very often with patients who have metastatic disease to their lungs from sarcomas.
The purpose of this study is to test the possibility of SBRT to the lung for metastatic disease to the lung. This information will be used to find out if there are factors that can predict recovery or outcome of patients with metastatic disease to the lung from sarcoma. SBRT will consist of 1 to 3 treatments per week for a total of 3 to 5 treatments to each tumor until therapy is complete. After SBRT is completed, follow-up exams will occur 4-6 weeks from the completion of radiation treatment, every 3 months in year 1 and every 6 months for 2 years.
3,514 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.
This study's enrollment of 9 is below the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
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Exclusion Criteria:
Arms: Stereotactic Body Radiation Therapy (SBRT) with Adaptive Radiation Therapy (ART) for all patients. A non-randomized study. Patients must have 1-5 pulmonary metastases all less than 5 cm in size. Pathologic confirmation of primary soft tissue sarcoma. All lesions to receive 3-5 fractions to each tumor. Treatments delivered with \> 10 Gy per fraction will have a minimum of 48 hour interfraction interval. For treatments with ≤ 10 Gy per fraction will have a minimum 24 hour interfraction interval. Treatments will be ideally completed over 14 days for 3 fraction treatments and over 21 days for \>5 fraction treatment schedules.
Radiation: SBRT
Stereotactic Body Radiation Therapy
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.
Time frame: 6 weeks post SBRT
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.
Time frame: 3 years
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.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, and 36 months
Overall Survival
This measure is the number of subjects alive at three years.
Time frame: 3 years
| Milestone | Stereotactic Body Radiation Therapy |
|---|---|
| Started | 9 |
| Completed | 8 |
| Not completed | 1 |
| Withdrew: Physician decision | 1 |
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.
| events | Stereotactic Body Radiation Therapy |
|---|---|
| Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria. | 8 |
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.
| Participants | Stereotactic Body Radiation Therapy |
|---|---|
| Number of Subjects Experiencing Locoregional Recurrences. | 0 |
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.
| units on a scale | Stereotactic Body Radiation Therapy |
|---|---|
| Baseline | 17.1 ± 1.5 |
| 6 Months | 16.7 ± 3.2 |
| 12 Months | 16.3 ± 1.9 |
| 18 Months | 16.4 ± 1.5 |
| 24 Months | 17.0 ± 1.5 |
| 36 Months | 17.1 ± 1.1 |
This measure is the number of subjects alive at three years.
| Participants | Stereotactic Body Radiation Therapy |
|---|---|
| Overall Survival | 5 |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | 3/8 (37.5%) | 3/8 (37.5%) | 8/8 (100%) |
| Event | Stereotactic Body Radiation Therapy |
|---|---|
| Disease progressionGeneral disorders | 3/8 |
| Event | Stereotactic Body Radiation Therapy |
|---|---|
| FatigueGeneral disorders | 4/8 |
| Lymphocyte count decreasedInvestigations | 2/8 |
| AnxietyPsychiatric disorders | 1/8 |
| DysphagiaGastrointestinal disorders | 1/8 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/8 |
| EsophagitisGastrointestinal disorders | 1/8 |
| HyperglycemiaMetabolism and nutrition disorders | 1/8 |
| HypertensionVascular disorders | 1/8 |
| ObesityMetabolism and nutrition disorders | 1/8 |
| Platelet count decreasedInvestigations | 1/8 |
| Age, Categorical(Participants) | Stereotactic Body Radiation Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 3 |
| Age, Continuous(years) | Stereotactic Body Radiation Therapy |
|---|---|
| Mean | 58.1 ± 13.9 |
| Sex: Female, Male(Participants) | Stereotactic Body Radiation Therapy |
|---|---|
| Female | 2 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Stereotactic Body Radiation Therapy |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Stereotactic Body Radiation Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Stereotactic Body Radiation Therapy |
|---|---|
| United States | 8 |
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Medical College of Wisconsin