Trial Outcomes & Findings for (SBRT) and (ART) for Pulmonary Metastases From Soft Tissue Sarcomas (NCT NCT01949506)
NCT ID: NCT01949506
Last Updated: 2023-02-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
6 weeks post SBRT
Results posted on
2023-02-28
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
(SBRT) and (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
Baseline characteristics by cohort
| Measure |
Stereotactic Body Radiation Therapy
n=8 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post SBRTThis 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.
Outcome measures
| Measure |
Stereotactic Body Radiation Therapy
n=8 Participants
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
|
|---|---|
|
Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria.
|
8 events
|
SECONDARY outcome
Timeframe: 3 yearsThis 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.
Outcome measures
| Measure |
Stereotactic Body Radiation Therapy
n=8 Participants
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
|
|---|---|
|
Number of Subjects Experiencing Locoregional Recurrences.
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 months, 12 months, 18 months, 24 months, and 36 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Stereotactic Body Radiation Therapy
n=8 Participants
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
|
|---|---|
|
Quality of Life Questionnaire Score
Baseline
|
17.1 units on a scale
Standard Deviation 1.5
|
|
Quality of Life Questionnaire Score
6 Months
|
16.7 units on a scale
Standard Deviation 3.2
|
|
Quality of Life Questionnaire Score
12 Months
|
16.3 units on a scale
Standard Deviation 1.9
|
|
Quality of Life Questionnaire Score
18 Months
|
16.4 units on a scale
Standard Deviation 1.5
|
|
Quality of Life Questionnaire Score
24 Months
|
17.0 units on a scale
Standard Deviation 1.5
|
|
Quality of Life Questionnaire Score
36 Months
|
17.1 units on a scale
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsThis measure is the number of subjects alive at three years.
Outcome measures
| Measure |
Stereotactic Body Radiation Therapy
n=8 Participants
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
|
|---|---|
|
Overall Survival
|
5 Participants
|
Adverse Events
Stereotactic Body Radiation Therapy
Serious events: 3 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Stereotactic Body Radiation Therapy
n=8 participants at risk
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
|
|---|---|
|
General disorders
Disease progression
|
37.5%
3/8 • Number of events 3 • 3 years
|
Other adverse events
| Measure |
Stereotactic Body Radiation Therapy
n=8 participants at risk
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
|
|---|---|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 4 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Obesity
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
General disorders
Burning sensation in chest
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
GERD
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • 3 years
|
Additional Information
Meena Bedi, MD
Froedtert and the Medical college of Wisconsin
Phone: 414-805-4400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place