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

Primary Purpose

Breast Cancer, Metastasis to Liver, Metastasis to Lung

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
stereotactic radiation therapy (SRT)
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring oligometastatic breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Istituto Clinico Humanitas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oligometastatic breast cancer patients

Arm Description

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

Outcomes

Primary Outcome Measures

Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4
Local control of disease after SBRT according to EORTC questionnaire

Secondary Outcome Measures

Progression free survival using Kaplan-Meyer statistical curves
Overall survival using Kaplan-Meyer statistical curves
Quality of life at the end of the treatment with questionnaire EORTC QLQ C30

Full Information

First Posted
October 15, 2015
Last Updated
May 3, 2022
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02581670
Brief Title
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer
Official Title
Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 4, 2015 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastasis to Liver, Metastasis to Lung
Keywords
oligometastatic breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oligometastatic breast cancer patients
Arm Type
Experimental
Arm Description
Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach.
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiation therapy (SRT)
Intervention Description
Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach
Primary Outcome Measure Information:
Title
Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4
Time Frame
3 years
Title
Local control of disease after SBRT according to EORTC questionnaire
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression free survival using Kaplan-Meyer statistical curves
Time Frame
2 months
Title
Overall survival using Kaplan-Meyer statistical curves
Time Frame
2 months
Title
Quality of life at the end of the treatment with questionnaire EORTC QLQ C30
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fiorenza De Rose, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tiziana Comito, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy

12. IPD Sharing Statement

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

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