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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Stereotactic Body Radiation Therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manpreet Bedi, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Body Radiation Therapy | 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. SBRT: Stereotactic Body Radiation Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Body Radiation Therapy | 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. SBRT: Stereotactic Body Radiation Therapy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | events | 6 weeks post SBRT |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stereotactic Body Radiation Therapy | 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. SBRT: Stereotactic Body Radiation Therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | CTCAE 4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meena Bedi, MD | Froedtert and the Medical college of Wisconsin | 414-805-4400 | mbedi@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2017 | Sep 30, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2017 | Sep 30, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 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. | 3 years |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Posted | Count of Participants | Participants | 3 years |
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| Other Pre-specified | 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. | Of the 8 subjects in the study, 3 expired within the 3-year timeframe. At their 36-month visit, 2 additional subjects did not complete the survey. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months, 12 months, 18 months, 24 months, and 36 months |
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| Other Pre-specified | Overall Survival | This measure is the number of subjects alive at three years. | Posted | Count of Participants | Participants | 3 years |
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| 3 |
| 8 |
| 3 |
| 8 |
| 8 |
| 8 |
| Dysphagia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Esophagitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Burning sensation in chest | General disorders | CTCAE 4.0 | Systematic Assessment |
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| GERD | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
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| 12 Months |
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| 18 Months |
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| 24 Months |
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| 36 Months |
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