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(SBRT) and (ART) for Pulmonary Metastases From Soft Tissue Sarcomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01949506
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : October 4, 2022
Information provided by (Responsible Party):
Meena Bedi, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment Phase
Stage IV Adult Soft Tissue Sarcoma Sarcoma,Soft Tissue Radiation: SBRT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Radiation: SBRT
Stereotactic Body Radiation Therapy

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Number of subjects experiencing locoregional recurrences. [ Time Frame: 3 years ]
    This measure (number of subjects experiencing locoregional recurrences) will provide information regarding locoregional control.

Other Outcome Measures:
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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

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United States, Wisconsin
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
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Principal Investigator: Manpreet Bedi, MD Medical College of Wisconsin
  Study Documents (Full-Text)

Documents provided by Meena Bedi, Medical College of Wisconsin:
Informed Consent Form  [PDF] March 27, 2017

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Responsible Party: Meena Bedi, Principal Investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01949506    
Other Study ID Numbers: PRO00020337
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Meena Bedi, Medical College of Wisconsin:
Lung metastases
Radiation Therapy
Stereotactic Body Radiation Therapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type