Breast Cancer, Metastasis to Liver, Metastasis to Lung
Conditions
Keywords
oligometastatic breast cancer
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.
Interventions
RADIATIONstereotactic radiation therapy (SRT)
Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Italy
Outcome results
None listed