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

Istituto Clinico Humanitas

Status: Unknown

Conditions: Metastasis to Lung; Breast Cancer; Metastasis to Liver

Treatments: Radiation: stereotactic radiation therapy (SRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02581670

1437

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Oligometastatic breast cancer patients

Experimental group

Description:

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

Treatment:

Radiation: stereotactic radiation therapy (SRT)