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

NCT01949506 | Completed Results DMC FDA Device

• 1 other identifier: PRO00020337
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Adult Soft Tissue Sarcoma; Sarcoma,Soft Tissue

Keywords

Lung metastases; Radiation Therapy; Stereotactic Body Radiation Therapy; Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Subjects Experiencing Locoregional Recurrences.

  3 years

Other Outcomes (2)

• Quality of Life Questionnaire Score

  Baseline, 6 months, 12 months, 18 months, 24 months, and 36 months

• Overall Survival

  3 years

Study Arms (1)

Stereotactic Body Radiation Therapy

OTHER

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

Interventions

SBRT RADIATION

Stereotactic Body Radiation Therapy

Stereotactic Body Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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
• pulmonary lesions all ≤5 cm in size
• Medically inoperable or declines surgery
• Patients may have had previous treatment for pulmonary metastases

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital and Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Meena Bedi, MD
• Organization: Froedtert and the Medical college of Wisconsin

mbedi@mcw.edu

414-805-4400

Study Officials

• Manpreet Bedi, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 24, 2013
• Study Start: September 24, 2013
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: February 28, 2023
• Results First Posted: February 28, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)