Breast CancerNCT02581670
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer
A study testing stereotactic radiation therapy (SRT) in people with Breast Cancer and Metastasis to Liver, run by Istituto Clinico Humanitas at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastasis to Liver, Metastasis to Lung
- What is being tested?
- stereotactic radiation therapy (SRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2015to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- ECOG > 2
- Pregnant women
- Patients with inability to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Metastasis to Liver, Metastasis to Lung
- Being tested
- stereotactic radiation therapy (SRT)
- Keywords
- oligometastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiation therapy (SRT)Radiation
Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach
| Study group | Role | What they receive |
|---|---|---|
| Oligometastatic breast cancer patients | Experimental | Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach. Receives: Radiation: stereotactic radiation therapy (SRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4
Measured: 3 years
Local control of disease after SBRT according to EORTC questionnaire
Measured: 2 years
Secondary outcomes (3)
Progression free survival using Kaplan-Meyer statistical curves
Measured: 2 months
Overall survival using Kaplan-Meyer statistical curves
Measured: 2 months
Quality of life at the end of the treatment with questionnaire EORTC QLQ C30
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start4 Nov 2015
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Fiorenza De Rose, MD, Principal investigator, Istituto Clinico HumanitasTiziana Comito, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581670
- Sponsor's protocol ID
- 1437
- Status last verified
- May 2022
- First submitted
- 15 Oct 2015
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer
- ClinicalTrials.gov ID
- NCT02581670
- Acronym / sponsor ID
- 1437
- Conditions
- Breast Cancer, Metastasis to Liver, Metastasis to Lung
- Keywords
- oligometastatic breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oligometastatic breast cancer patients | Experimental | Radiation: stereotactic radiation therapy (SRT)Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- ECOG > 2
- Pregnant women
- Patients with inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic radiation therapy (SRT)Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach | Radiation | Oligometastatic breast cancer patients |
Primary outcome
Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4
Time frame: 3 years
Local control of disease after SBRT according to EORTC questionnaire
Time frame: 2 years
3 secondary outcomes
Progression free survival using Kaplan-Meyer statistical curves
Time frame: 2 months
Overall survival using Kaplan-Meyer statistical curves
Time frame: 2 months
Quality of life at the end of the treatment with questionnaire EORTC QLQ C30
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiorenza De Rose, MD principal investigator
Istituto Clinico Humanitas
Tiziana Comito, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic radiation therapy (SRT) in people with Breast Cancer and Metastasis to Liver, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4 (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.