Sarcoma,Soft Tissue, Stage IV Adult Soft Tissue Sarcoma
Conditions
Keywords
Lung metastases, Radiation Therapy, Stereotactic Body Radiation Therapy, Sarcoma
Brief 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.
Detailed description
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.
Interventions
RADIATIONSBRT
Stereotactic Body Radiation Therapy
Sponsors
Medical College of Wisconsin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing Locoregional Recurrences. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire Score | 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. |
| Overall Survival | 3 years | This measure is the number of subjects alive at three years. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Stereotactic Body Radiation Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 58.1 years STANDARD_DEVIATION 13.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 8 |
| other Total, other adverse events | 8 / 8 |
| serious Total, serious adverse events | 3 / 8 |
Outcome results
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.
Time frame: 6 weeks post SBRT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stereotactic Body Radiation Therapy | Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria. | 8 events |
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.
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stereotactic Body Radiation Therapy | Number of Subjects Experiencing Locoregional Recurrences. | 0 Participants |
Other Pre-specified
Overall Survival
This measure is the number of subjects alive at three years.
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stereotactic Body Radiation Therapy | Overall Survival | 5 Participants |
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.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, and 36 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | Quality of Life Questionnaire Score | Baseline | 17.1 units on a scale | Standard Deviation 1.5 |
| Stereotactic Body Radiation Therapy | Quality of Life Questionnaire Score | 6 Months | 16.7 units on a scale | Standard Deviation 3.2 |
| Stereotactic Body Radiation Therapy | Quality of Life Questionnaire Score | 12 Months | 16.3 units on a scale | Standard Deviation 1.9 |
| Stereotactic Body Radiation Therapy | Quality of Life Questionnaire Score | 18 Months | 16.4 units on a scale | Standard Deviation 1.5 |
| Stereotactic Body Radiation Therapy | Quality of Life Questionnaire Score | 24 Months | 17.0 units on a scale | Standard Deviation 1.5 |
| Stereotactic Body Radiation Therapy | Quality of Life Questionnaire Score | 36 Months | 17.1 units on a scale | Standard Deviation 1.1 |