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SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02561559
Enrollment
37
Registered
2015-09-28
Start date
2015-06-10
Completion date
2023-01-31
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastasis From Malignant Tumor of Soft Tissues

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.

Interventions

RADIATIONLung metastasis from soft-tissue sarcoma

Tretament based on Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT)

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Local control of treated lesions12 monthsEvaluation of proportion of patients free from progression from starting radiotherapy

Secondary

MeasureTime frameDescription
Overall survival of treated patients4 yearsEvaluation of proportion of patients alive
Disease free survival of treated patients4 yearsEvaluation of proportion of patients alive and free from progression

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026