SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma

Metastasis From Malignant Tumor of Soft Tissues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02561559
• Other study ID #: 1393
• Status: Active, not recruiting
• Start date: June 10, 2015
• Est. completion date: January 2023

Study information

• Verified date: May 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastasis From Malignant Tumor of Soft Tissues
• Neoplasm Metastasis
• Neoplasms
• Sarcoma
• Soft Tissue Neoplasms

Intervention

Radiation:
• Lung metastasis from soft-tissue sarcoma
Tretament based on Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT)

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano, MI	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Navarria P, Ascolese AM, Cozzi L, Tomatis S, D'Agostino GR, De Rose F, De Sanctis R, Marrari A, Santoro A, Fogliata A, Cariboni U, Alloisio M, Quagliuolo V, Scorsetti M. Stereotactic body radiation therapy for lung metastases from soft tissue sarcoma. Eur J Cancer. 2015 Mar;51(5):668-74. doi: 10.1016/j.ejca.2015.01.061. Epub 2015 Feb 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control of treated lesions	Evaluation of proportion of patients free from progression from starting radiotherapy	12 months
Secondary	Overall survival of treated patients	Evaluation of proportion of patients alive	4 years
Secondary	Disease free survival of treated patients	Evaluation of proportion of patients alive and free from progression	4 years