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

NCT ID: NCT01949506

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-24
• Study Completion Date: 2019-10-04

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.

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.

Conditions

Stage IV Adult Soft Tissue Sarcoma; Sarcoma,Soft Tissue

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

SBRT

Intervention Type: RADIATION

Stereotactic Body Radiation Therapy

Interventions

SBRT

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Meena Bedi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manpreet Bedi, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert Hospital and Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PRO00020337

Identifier Type: -

Identifier Source: org_study_id