A Study For Using Radiosurgery On Limited Metastases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study For Using Radiosurgery On Limited Metastases

Conditions
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Neoplasms, Metastatic

Intervention / Treatment
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* Procedure: Stereotactic Body Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic body radiation therapy<br> | Procedure: Stereotactic Body Radiation Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |