A Study For Using Radiosurgery On Limited Metastases
|First Received Date ICMJE||September 12, 2005|
|Last Updated Date||July 28, 2010|
|Start Date ICMJE||April 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To determine the feasibility and potential utility of radiosurgery for limited metastatic disease, compared to historical controls.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00178399 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Study For Using Radiosurgery On Limited Metastases|
|Official Title ICMJE||A Pilot Study For Using Radiosurgery On Limited Metastases|
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Neoplasms, Metastatic|
|Intervention ICMJE||Procedure: Stereotactic Body Radiation Therapy|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Suspended|
|Estimated Enrollment ICMJE||300|
|Estimated Completion Date||April 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00178399|
|Other Study ID Numbers ICMJE||URCC 9700|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Michael Milano, MD PhD, University of Rochester|
|Study Sponsor ICMJE||University of Rochester|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Rochester|
|Verification Date||July 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP