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

Istituto Clinico Humanitas65 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Metastasis to Liver Metastasis to Lung

Interventions

stereotactic radiation therapy (SRT)RADIATION

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * ECOG \> 2 * Pregnant women * Patients with inability to consent

Locations (1)

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Outcomes

Primary Outcomes

Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4

Time frame: 3 years

Local control of disease after SBRT according to EORTC questionnaire

Time frame: 2 years

Secondary Outcomes

Progression free survival using Kaplan-Meyer statistical curves

Time frame: 2 months

Overall survival using Kaplan-Meyer statistical curves

Time frame: 2 months

Quality of life at the end of the treatment with questionnaire EORTC QLQ C30

Time frame: 2 months

Data from ClinicalTrials.gov

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