SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma

• Conditions: Metastasis From Malignant Tumor of Soft Tissues
• Interventions: Radiation: Lung metastasis from soft-tissue sarcoma

• Registration Number: NCT02561559
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2015-06-10
• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-09-25
• Study First Posted: 2015-09-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung metastasis from soft-tissue sarcoma	Lung metastasis from soft-tissue sarcoma	Lung metastases from soft-tissue sarcoma

Primary Outcome Measures

Name	Time	Method
Local control of treated lesions	12 months	Evaluation of proportion of patients free from progression from starting radiotherapy

Secondary Outcome Measures

Name	Time	Method
Overall survival of treated patients	4 years	Evaluation of proportion of patients alive
Disease free survival of treated patients	4 years	Evaluation of proportion of patients alive and free from progression

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, MI, Milan, Italy