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The standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or hormonal therapy alone or in combination. The main purpose of this study is to evaluate whether radiosurgery alone affects your quality and length of life. A second purpose of this study is to determine if the levels of special types of protein (called cytokines) found in the blood are related to your quality of life during your course of treatment and follow-up.
In this research study high dose stereotactic body radiation therapy will be 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. Blood for the cytokine tests will be drawn before your therapy starts, weekly during therapy and at the follow-up visits as stated in the next paragraphs. Two to four tablespoons of blood will be removed each time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic body radiation therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Curatively Treated Patients With Progression-free Survival | Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions. | 24 months |
| Percentage of Palliatively Treated Patients With Progression-free Survival | Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles | Correlation of data from QOL questionnaires and blood markers. | 30 months from date of registration. |
| Analyze Impact of Disease Bulk and Number of Sites Involved. |
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Inclusion Criteria:
Age ≥ 18 years
KPS ≥ 70
Palliative: Disease most likely to be life limiting, is definable, and treatable to a sterilizing dose according to protocol criteria.
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. Previously enrolled patients can be retreated to new lesions if they still meet protocol requirements.
Informed consent must be obtained.
Pregnancy test must be negative for women of child bearing potential.
Out of state patients are eligible, if communication with the referring physicians is expected to be adequate to address the primary aim. The secondary aim (blood cytokines) is optional for out-of-state patients.
Exclusion Criteria:
Technical inability to achieve required dose based on safe dose constraints required for radiosurgery
Women who are pregnant or nursing..
Failure to meet inclusion requirements
Contraindications to radiation.
Patient should not be eligible for primary disease specific radiosurgical protocols
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| Name | Affiliation | Role |
|---|---|---|
| Michael Milano, MD PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Department of Radiation Oncology | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Body Radiation Therapy | Stereotactic Body Radiation Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Body Radiation Therapy | Stereotactic Body Radiation Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Percentage of Curatively Treated Patients With Progression-free Survival | Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions. | Only curative patients were included in this analysis | Posted | Number | percentage of participants | 24 months |
|
|
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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 | Stereotactic Body Radiation Therapy | Stereotactic Body Radiation Therapy | 123 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis/Pulmonary Infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Milano | University of Rochester | 585-273-4096 | michael_milano@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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Analysis or response and progression. |
| From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Percentage of Palliatively Treated Patients With Progression-free Survival | Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease. | Only palliative patients were included in this analysis | Posted | Number | percentage of participants | 24 months |
|
|
|
| Secondary | Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles | Correlation of data from QOL questionnaires and blood markers. | No data was collected for this outcome measure. | Posted | 30 months from date of registration. |
|
|
| Secondary | Analyze Impact of Disease Bulk and Number of Sites Involved. | Analysis or response and progression. | No data was collected for this outcome measure. | Posted | From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years |
|
|
| 128 |
| 0 |
| 128 |
| 24 |
| 128 |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pericardial effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |