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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02581670
• Other study ID #: 1437
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 4, 2015
• Est. completion date: October 2023

Study information

• Verified date: May 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastasis to Liver
• Metastasis to Lung
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4		3 years
Primary	Local control of disease after SBRT according to EORTC questionnaire		2 years
Secondary	Progression free survival using Kaplan-Meyer statistical curves		2 months
Secondary	Overall survival using Kaplan-Meyer statistical curves		2 months
Secondary	Quality of life at the end of the treatment with questionnaire EORTC QLQ C30		2 months