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

Stage IV Adult Soft Tissue Sarcoma Clinical Trial

Official title:

Pilot Study Evaluating Stereotactic Body Radiation Therapy (SBRT) and Adaptive Radiation Therapy (ART) for Pulmonary Metastases From Soft Tissue Sarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949506
• Other study ID #: PRO00020337
• Status: Completed
• Phase: N/A
• Start date: September 24, 2013
• Est. completion date: October 4, 2019

Study information

• Verified date: January 2023
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Sarcoma
• Sarcoma,Soft Tissue
• Stage IV Adult Soft Tissue Sarcoma

Intervention

Radiation:
• SBRT
Stereotactic Body Radiation Therapy

Locations

Country	Name	City	State
United States	Froedtert Hospital and Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline, 6 months, 12 months, 18 months, 24 months, and 36 months
Other	Overall Survival	This measure is the number of subjects alive at three years.	3 years
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.	6 weeks post SBRT
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.	3 years