SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma

Study Overview
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Brief Summary
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In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from STS.

Detailed Description
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The investigators started to treat PM oligometastatic patients with Stereotactic Body Radiotherapy. The investigators objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from soft-tissue sarcomas. Overall and disease free survival will be evaluated as secondary endpoints.

Official Title
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Phase II Study to Evaluate Feasibility and Safety of Stereotactic Body Radiation Radiotherapy (SBRT) for Lung Metastases From Soft Tissue Sarcoma

Conditions
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Metastasis From Malignant Tumor of Soft Tissues

Intervention / Treatment
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* Radiation: Lung metastasis from soft-tissue sarcoma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 anni -85 years PS according to ECOG 0-2 Histopathologically confirmation of soft tissue sarcoma Metastatic lung lesion less than 4 Controlled primary tumor and other metastatic lesions Metastatic lesion less than 5 such as the definition of oligometastatic patients Written informed consent Contraindication to surgical resection Estimated survival ≥ 3 months Absence of progressive disease longer than 6 months No chemotherapy was given for at least 3 months after SBRT Maximum diameter ≤ 5 cm Exclusion Criteria: Prior thorax radiation therapy Age > 85 years PS according to ECOG >2 Pregnant women Maximum diameter ≥ 5.1 cm Total volume of lung lesion greater than 1/3 of the whole pulmonary parenchima

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung metastasis from soft-tissue sarcoma<br>Lung metastases from soft-tissue sarcoma | Radiation: Lung metastasis from soft-tissue sarcoma<br>* Tretament based on Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control of treated lesions | Evaluation of proportion of patients free from progression from starting radiotherapy | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival of treated patients | Evaluation of proportion of patients alive | 4 years | 
| Disease free survival of treated patients | Evaluation of proportion of patients alive and free from progression | 4 years |