Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Istituto Clinico Humanitas
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Local control of disease after SBRT according to EORTC questionnaire
- Last Updated
- 3 years ago
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.
Investigators
Michele Tedeschi
MD
Istituto Clinico Humanitas
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
Outcomes
Primary Outcomes
Local control of disease after SBRT according to EORTC questionnaire
Time Frame: 2 years
Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4
Time Frame: 3 years
Secondary Outcomes
- Overall survival using Kaplan-Meyer statistical curves(2 months)
- Progression free survival using Kaplan-Meyer statistical curves(2 months)
- Quality of life at the end of the treatment with questionnaire EORTC QLQ C30(2 months)