(SBRT) and (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
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|ClinicalTrials.gov Identifier: NCT01949506|
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : October 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Adult Soft Tissue Sarcoma Sarcoma,Soft Tissue||Radiation: SBRT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Evaluating Stereotactic Body Radiation Therapy (SBRT) and Adaptive Radiation Therapy (ART) for Pulmonary Metastases From Soft Tissue Sarcomas|
|Actual Study Start Date :||September 24, 2013|
|Actual Primary Completion Date :||October 4, 2019|
|Actual Study Completion Date :||October 4, 2019|
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.
Stereotactic Body Radiation Therapy
- Number of adverse events of grade ≥ 3 by CTCAE criteria. [ Time Frame: 6 weeks post SBRT ]This measure (number of adverse events of grade ≥ 3 by CTCAE criteria) will provide information regarding the acute toxicity of SBRT for < 5 pulmonary metastases from soft tissue sarcoma.
- Number of subjects experiencing locoregional recurrences. [ Time Frame: 3 years ]This measure (number of subjects experiencing locoregional recurrences) will provide information regarding locoregional control.
- Quality of Life Questionnaire Score [ Time Frame: 3 years ]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.
- Overall survival as measured by the number of subjects alive at three years. [ Time Frame: 3 years ]This measure is the number of subjects alive at three years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949506
|United States, Wisconsin|
|Froedtert Hospital and Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Manpreet Bedi, MD||Medical College of Wisconsin|