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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer

Conditions
-----------------
Breast Cancer, Metastasis to Liver, Metastasis to Lung

Intervention / Treatment
-----------------
* Radiation: stereotactic radiation therapy (SRT)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oligometastatic breast cancer patients<br>Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach. | Radiation: stereotactic radiation therapy (SRT)<br>* Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4 |  | 3 years | 
| Local control of disease after SBRT according to EORTC questionnaire |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival using Kaplan-Meyer statistical curves |  | 2 months | 
| Overall survival using Kaplan-Meyer statistical curves |  | 2 months | 
| Quality of life at the end of the treatment with questionnaire EORTC QLQ C30 |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oligometastatic breast cancer