Phase II Study to Evaluate Feasibility and Safety of Stereotactic Body Radiation Radiotherapy (SBRT) for Lung Metastases From Soft Tissue Sarcoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastasis From Malignant Tumor of Soft Tissues
- Sponsor
- Istituto Clinico Humanitas
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Local control of treated lesions
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Michele Tedeschi
MD
Istituto Clinico Humanitas
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Local control of treated lesions
Time Frame: 12 months
Evaluation of proportion of patients free from progression from starting radiotherapy
Secondary Outcomes
- Overall survival of treated patients(4 years)
- Disease free survival of treated patients(4 years)