SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma

NCT ID: NCT02561559

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-10

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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Metastasis From Malignant Tumor of Soft Tissues

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung metastasis from soft-tissue sarcoma

Lung metastases from soft-tissue sarcoma

Lung metastasis from soft-tissue sarcoma

Intervention Type RADIATION

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

Interventions

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Lung metastasis from soft-tissue sarcoma

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Michele Tedeschi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marta Scorsetti, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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Istituto Clinico Humanitas

Rozzano, MI, Milan, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 25686482 (View on PubMed)

Other Identifiers

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1393

Identifier Type: -

Identifier Source: org_study_id

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