- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02581670
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer
May 3, 2022 updated by: Michele Tedeschi, Istituto Clinico Humanitas
Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Milano
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Rozzano, Milano, Italy, 20089
- Istituto Clinico Humanitas
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oligometastatic breast cancer patients
Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach.
|
Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4
Time Frame: 3 years
|
3 years
|
Local control of disease after SBRT according to EORTC questionnaire
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival using Kaplan-Meyer statistical curves
Time Frame: 2 months
|
2 months
|
Overall survival using Kaplan-Meyer statistical curves
Time Frame: 2 months
|
2 months
|
Quality of life at the end of the treatment with questionnaire EORTC QLQ C30
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fiorenza De Rose, MD, Istituto Clinico Humanitas
- Principal Investigator: Tiziana Comito, MD, Istituto Clinico Humanitas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 4, 2015
Primary Completion (Anticipated)
October 1, 2023
Study Completion (Anticipated)
October 1, 2023
Study Registration Dates
First Submitted
October 15, 2015
First Submitted That Met QC Criteria
October 20, 2015
First Posted (Estimate)
October 21, 2015
Study Record Updates
Last Update Posted (Actual)
May 4, 2022
Last Update Submitted That Met QC Criteria
May 3, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1437
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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