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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy | Experimental | Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy | Procedure | Hypofractionated Stereotactic Body Radiation Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The percent of patients that survived from date of enrollment until 2 year follow-up visit. | 2 years |
| Overall Survival | The percent of patients that survived from date of enrollment until 4 year follow-up visit | 4 years |
| Overall Survival | The percent of patients that survived from date of enrollment until 6 year follow-up visit | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Zhang, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology: University of Rochester | Rochester | New York | 14642 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this study: Using Radiosurgery On Limited Metastases Of Breast Cancer | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypofractionated Stereotactic Body Radiation Therapy | Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypofractionated Stereotactic Body Radiation Therapy | Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | The percent of patients that survived from date of enrollment until 2 year follow-up visit. | Posted | Number | percentage of participants | 2 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypofractionated Stereotactic Body Radiation Therapy | Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary. Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy Hypofractionated Stereotactic Body Radiation Therapy: Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nonmalignant pleural and pericardial effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hong Zhang | University of Rochester | 585-341-6750 | hong_zhang@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Hypofractionated Stereotactic Body Radiation Therapy | Radiation | Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary. |
|
| Number of Participants Who Experienced a Grade 4 or 5 Toxicity | Number of participants who experienced a grade 4 or 5 toxicity | 6 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Participants |
|
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| Primary | Overall Survival | The percent of patients that survived from date of enrollment until 4 year follow-up visit | Posted | Number | percentage of participants | 4 years |
|
|
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| Primary | Overall Survival | The percent of patients that survived from date of enrollment until 6 year follow-up visit | Posted | Number | percentage of participants | 6 years |
|
|
|
| Secondary | 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. | Posted | Number | percentage of participants | 6 years |
|
|
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| Secondary | Number of Participants Who Experienced a Grade 4 or 5 Toxicity | Number of participants who experienced a grade 4 or 5 toxicity | Posted | Count of Participants | Participants | 6 years |
|
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| 0 |
| 39 |
| 1 |
| 39 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |