SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma

May 3, 2022 updated by: Michele Tedeschi, Istituto Clinico Humanitas

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Rozzano, MI, Milan, Italy, 20089
        • Istituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients affected by soft-tissue sarcomas with lung metastases unsuitable for surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lung metastasis from soft-tissue sarcoma
Lung metastases from soft-tissue sarcoma
Radiation: Lung metastasis from soft-tissue sarcoma
Tretament based on Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control of treated lesions
Time Frame: 12 months
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
Time Frame: 4 years
Evaluation of proportion of patients alive
4 years
Disease free survival of treated patients
Time Frame: 4 years
Evaluation of proportion of patients alive and free from progression
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Marta Scorsetti, MD, Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2015

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 25, 2015

First Submitted That Met QC Criteria

September 25, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1393

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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