Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer

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

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-04

Study Completion Date

2023-10-31

Brief Summary

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Investigators designed a phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach.

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Detailed Description

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Investigators designed a prospective phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) scheduled for oligometastatic breast cancer patients unsuitable for surgery with age major than 18 years old and with adequate performance status (ECOG), using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.

Conditions

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Breast Cancer Metastasis to Liver Metastasis to Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oligometastatic breast cancer patients

Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach.

Group Type EXPERIMENTAL

stereotactic radiation therapy (SRT)

Intervention Type RADIATION

Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach

Interventions

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stereotactic radiation therapy (SRT)

Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients aged \>18 years with ECOG 0-2
* Diagnosis of Breast Cancer
* DFI (Disease-free interval) \> 1 year
* No extrapulmonary and/or extrahepatic disease or other metastatic sites stable or responding after chemotherapy
* No life threatening conditions
* Lung and liver lesions \< 5 (with maximum diameter \< 5 cm)
* Chemotherapy completed at least 3 weeks before treatment
* Chemotherapy started at least 2 weeks after treatment allowed
* Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy)
* Written informed consent