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

Not Applicable

• Conditions: Breast Cancer; Metastasis to Liver; Metastasis to Lung
• Interventions: Radiation: stereotactic radiation therapy (SRT)

• Registration Number: NCT02581670
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Study Start: 2015-11-04
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Local control of disease after SBRT according to EORTC questionnaire	2 years
Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy