Breast Cancer Metastatic to the LiverPhase 2SIRTNCT00891800
Brachytherapy Radiation Directly to the Liver in Breast Cancer Patients With Metastatic to Liver
A Phase 2 study testing Brachytherapy and SIR-Sphere in people with Breast Cancer Metastatic to the Liver, run by St. Joseph's Hospital, Florida at 1 site in United States.
Trial summary
The purpose of this study to study whether or not the use of direct radiation therapy with Y-90 microspheres (SIR-Spheres) has any effect on treated liver with respect to tumor response in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer Metastatic to the Liver
- What is being tested?
- Brachytherapy and SIR-Sphere
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2010
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented breast cancer
- Clinical evidence of mets to the liver
- Performance status of 0-2
- Life expectancy of greater equal to 3 months
- Not pregnant
- 4 weeks or more since last radiation therapy
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- Recovered from all side effects of prior chemotherapy
- Not needing concurrent chemotherapy
- recovered laboratory values
- Bilirubin < 2.0
Who cannot join
- Candidate for surgical resection or ablation of liver lesion/s
- Prior radiation therapy to the liver
- Co-Morbid disease
- pulmonary insufficiency
- Portal vein thrombosis
- Contraindications to angiography
Show all 12Show fewer
- > 20 % lung shunting on MAA
- Diffuse extra-hepatic disease
- Concurrent chemotherapy OR capecitabine with 8 weeks
- Failed MAA
- Uncontrolled active infection
- Severe liver dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital, Department of Radiation Therapy
Tampa, Florida, 33607
About this study
Official title: A Phase II Feasibility Study to Assess the Use of SIR-Sphere in Patients With Breast Cancer Who Have Chemotherapy-Resistant Disease in the Liver
The purpose of this study to study whether or not the use of direct radiation therapy with Y-90 microspheres (SIR-Spheres) has any effect on treated liver with respect to tumor response in breast cancer patients.
Criteria:
- Breast cancer
- Clinical evidence of metastatic disease in the liver
- Performance status (0-2)
- Not pregnant
- Laboratory values received after any prior chemotherapy
- Normal Pt/PTT
- recovered from any chemotherapy side-effects
- No prior radiation therapy to the liver
- No other MAJOR site of cancer such as lungs or brain
- No uncontrolled infections
- a candidate for surgical resection or ablation therapy
Read the detailed description
Patient must pass an MAA angiography study to detect abnormal shunting of the vessels to the lungs and stomach. Shunting of the radiation seeds to these areas, if an abnormality exists would be harmful.
- Conditions
- Breast Cancer Metastatic to the Liver
- Being tested
- Brachytherapy, SIR-Sphere
- Keywords
- Cancer, Breast, Liver
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyDevice
Also called Radiation seeds
SIR-Sphere contains radiation of Y-90.
SIR-SphereDevice
Brachytherapy Radiation seeds
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All patients will be treated with SIR-Sphere therapy. Receives: Device: Brachytherapy; Device: SIR-Sphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Assessment of the feasibility of SIRT treatment as measured by tumor response in the treated labe/s of the liver.Assessed by CT scan and measurement Secondary Response: Assessment of treatment toxicity. Assessed by examination and blood work.
Measured: Patients will be followed for 5 years or Progressive disease in the treated liver or until such time as systemic therapy is needed for disease in other organs which will affect tumor response in the liver.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startJul 2007
- Primary completionJul 2010
- Study completionDec 2010
Why it stopped: Lack of study patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Metastatic to the LiverStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital, Florida
- Sponsor type
- University, hospital or other
- Investigators
- ALison R Calkins, MD, Principal investigator, St. Joseph's Hospital, Department of Radiation Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891800
- Sponsor's protocol ID
- SJCI023
- Other IDs
- IDE # G050256
- Acronym
- SIRT
- Status last verified
- Jul 2010
- First submitted
- 29 Apr 2009
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Feasibility Study to Assess the Use of SIR-Sphere in Patients With Breast Cancer Who Have Chemotherapy-Resistant Disease in the Liver
- ClinicalTrials.gov ID
- NCT00891800
- Acronym / sponsor ID
- SIRT / SJCI023
- Conditions
- Breast Cancer Metastatic to the Liver
- Keywords
- Cancer, Breast, Liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of study patients
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Joseph's Hospital, FloridaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 May 2009 (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.
The purpose of this study to study whether or not the use of direct radiation therapy with Y-90 microspheres (SIR-Spheres) has any effect on treated liver with respect to tumor response in breast cancer patients.
Criteria:
- Breast cancer
- Clinical evidence of metastatic disease in the liver
- Performance status (0-2)
- Not pregnant
- Laboratory values received after any prior chemotherapy
- Normal Pt/PTT
- recovered from any chemotherapy side-effects
- No prior radiation therapy to the liver
- No other MAJOR site of cancer such as lungs or brain
- No uncontrolled infections
- a candidate for surgical resection or ablation therapy
Detailed description
Patient must pass an MAA angiography study to detect abnormal shunting of the vessels to the lungs and stomach. Shunting of the radiation seeds to these areas, if an abnormality exists would be harmful.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Brachytherapy, Device: SIR-SphereAll patients will be treated with SIR-Sphere therapy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Documented breast cancer
- Clinical evidence of mets to the liver
- Performance status of 0-2
- Life expectancy of greater equal to 3 months
- Not pregnant
Key exclusion criteria (12 listed)
- Candidate for surgical resection or ablation of liver lesion/s
- Prior radiation therapy to the liver
- Co-Morbid disease
- pulmonary insufficiency
- Portal vein thrombosis
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 |
|---|---|---|
| BrachytherapyAlso: Radiation seedsSIR-Sphere contains radiation of Y-90. | Device | 1 |
| SIR-SphereBrachytherapy Radiation seeds | Device | 1 |
Primary outcome
Primary: Assessment of the feasibility of SIRT treatment as measured by tumor response in the treated labe/s of the liver.Assessed by CT scan and measurement Secondary Response: Assessment of treatment toxicity. Assessed by examination and blood work.
Time frame: Patients will be followed for 5 years or Progressive disease in the treated liver or until such time as systemic therapy is needed for disease in other organs which will affect tumor response in the liver.
Results and safety
The study was stopped early (reason given: Lack of study patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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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.
ALison R Calkins, MD principal investigator
St. Joseph's Hospital, Department of Radiation Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brachytherapy and SIR-Sphere in people with Breast Cancer Metastatic to the Liver, run by St. Joseph's Hospital, Florida at 1 site in United States.
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 12 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: stopped early, as of the sponsor's last update on 7 Jun 2011. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of study patients). 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?
Primary: Assessment of the feasibility of SIRT treatment as measured by tumor response in the treated labe/s of the liver.Assessed by CT scan and measurement Secondary Response: Assessment of treatment toxicity. Assessed by examination and blood work. (time frame: Patients will be followed for 5 years or Progressive disease in the treated liver or until such time as systemic therapy is needed for disease in other organs which will affect tumor response in the liver.). 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 7 Jun 2011.