Breast Cancer, MetastaticNCT00167414
Study for Using Radiosurgery on Limited Metastases of Breast Cancer
A study testing Hypofractionated Stereotactic Body Radiation Therapy in people with Breast Cancer, Metastatic, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether radiosurgery, along with standard chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and immune response), or hormonal therapy, affects the quality and length of life. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Metastatic
- What is being tested?
- Hypofractionated Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to 1 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: no limit
- Karnofsky performance status (KPS) ≥ 70
- No more than 5 metastatic sites involving one or more different organs (liver, lung or bone).
- The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol.
- Previously treated lesions are not eligible unless the prescribed dose can be safely delivered.
- Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist.
- Informed consent must be obtained.
- Pregnancy test must be negative for women of child bearing potential
Who cannot join
- Inability of patient to be followed longitudinally as specified by protocol.
- Technical inability to achieve required dose based on safe dose constraints required for radiosurgery.
- Women who are pregnant or nursing.
- Failure to meet requirements in Inclusion Criteria
- Contraindications to radiation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Radiation Oncology: University of Rochester
Rochester, New York, 14642
About this study
Official title: A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer
The purpose of this study is to evaluate whether radiosurgery, along with standard chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and immune response), or hormonal therapy, affects the quality and length of life. The standard therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second purpose of this study is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to the quality of life while on this treatment.
Read the detailed description
Before treatment begins, you will have a physical exam and blood tests. Physical evaluations and blood tests will be done each week while you are receiving treatment, and at follow-up visits. You will be seen for follow-up evaluations 4 weeks after treatment is completed, and every three months thereafter. You will be asked to fill out a Quality of Life questionnaire, which should take 5-10 minutes to complete. This will be done prior to treatment and at your follow-up visits. You will receive high dose radiation therapy directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated.
- Conditions
- Breast Cancer, Metastatic
- Being tested
- Hypofractionated Stereotactic Body Radiation Therapy
- Keywords
- conformal radiotherapy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Stereotactic Body Radiation TherapyProcedure or surgery
Hypofractionated Stereotactic Body Radiation Therapy
Hypofractionated Stereotactic Body Radiation TherapyRadiation
Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy | Experimental | Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Receives: Procedure: Hypofractionated Stereotactic Body Radiation Therapy; Radiation: Hypofractionated Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
The percent of patients that survived from date of enrollment until 2 year follow-up visit.
Measured: 2 years
Overall Survival
The percent of patients that survived from date of enrollment until 4 year follow-up visit
Measured: 4 years
Overall Survival
The percent of patients that survived from date of enrollment until 6 year follow-up visit
Measured: 6 years
Secondary outcomes (2)
Percent of Patients With Lesion Local Control
Lesion local failure was scored as an event if any treated lesion increased by greater than or equal to 20% using the Response Evaluation Criteria in Solid Tumors criteria or local failure was confirmed pathologically. Lesion control includes all participants that did not fall into the category of lesion failure.
Measured: 6 years
Number of Participants Who Experienced a Grade 4 or 5 Toxicity
Number of participants who experienced a grade 4 or 5 toxicity
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startDec 2000
- Primary completion1 Nov 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer, MetastaticStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Zhang, University of Rochester
- Investigators
- Hong Zhang, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167414
- Sponsor's protocol ID
- URCC 8700
- Status last verified
- Dec 2017
- First submitted
- 9 Sep 2005
- Last updated
- 5 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer
- ClinicalTrials.gov ID
- NCT00167414
- Acronym / sponsor ID
- URCC 8700
- Conditions
- Breast Cancer, Metastatic
- Keywords
- conformal radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Dec 2000 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 5 Jan 2018
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 is to evaluate whether radiosurgery, along with standard chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and immune response), or hormonal therapy, affects the quality and length of life. The standard therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second purpose of this study is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to the quality of life while on this treatment.
Detailed description
Before treatment begins, you will have a physical exam and blood tests. Physical evaluations and blood tests will be done each week while you are receiving treatment, and at follow-up visits. You will be seen for follow-up evaluations 4 weeks after treatment is completed, and every three months thereafter. You will be asked to fill out a Quality of Life questionnaire, which should take 5-10 minutes to complete. This will be done prior to treatment and at your follow-up visits. You will receive high dose radiation therapy directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy | Experimental | Procedure: Hypofractionated Stereotactic Body Radiation Therapy, Radiation: Hypofractionated Stereotactic Body Radiation TherapyUse of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age: no limit
- Karnofsky performance status (KPS) ≥ 70
- No more than 5 metastatic sites involving one or more different organs (liver, lung or bone).
- The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol.
- Previously treated lesions are not eligible unless the prescribed dose can be safely delivered.
Key exclusion criteria (5 listed)
- Inability of patient to be followed longitudinally as specified by protocol.
- Technical inability to achieve required dose based on safe dose constraints required for radiosurgery.
- Women who are pregnant or nursing.
- Failure to meet requirements in Inclusion Criteria
- Contraindications to radiation.
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 |
|---|---|---|
| Hypofractionated Stereotactic Body Radiation TherapyHypofractionated Stereotactic Body Radiation Therapy | Procedure or surgery | Hypofractionated Stereotactic Body Radiation Therapy |
| Hypofractionated Stereotactic Body Radiation TherapyHypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary. | Radiation | Hypofractionated Stereotactic Body Radiation Therapy |
Primary outcome
Overall Survival
Time frame: 2 years
The percent of patients that survived from date of enrollment until 2 year follow-up visit.
Overall Survival
Time frame: 4 years
The percent of patients that survived from date of enrollment until 4 year follow-up visit
Overall Survival
Time frame: 6 years
The percent of patients that survived from date of enrollment until 6 year follow-up visit
2 secondary outcomes
Percent of Patients With Lesion Local Control
Time frame: 6 years
Number of Participants Who Experienced a Grade 4 or 5 Toxicity
Time frame: 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study: Using Radiosurgery On Limited Metastases Of Breast CancerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hong Zhang, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Stereotactic Body Radiation Therapy in people with Breast Cancer, Metastatic, run by University of Rochester 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 5 Jan 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (time frame: 2 years). The study lists 3 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 5 Jan 2018.