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A Study For Using Radiosurgery On Limited Metastases

This study has been suspended.
Study NCT00178399.   Last updated on September 6, 2006.   Information provided by University of Rochester

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Descriptive Information Fields
Brief Title  A Study For Using Radiosurgery On Limited Metastases
Official Title  A Pilot Study For Using Radiosurgery On Limited Metastases
Brief Summary

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

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 Phase
Study Type  Interventional
Study Design  Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  To determine the feasibility and potential utility of radiosurgery for limited metastatic disease, compared to historical controls.
Secondary Outcome Measure  Quality of life and correlation with pro-apoptotic, inflammatory, and anabolic cytokine profiles
Analyze impact of disease bulk and number of sites involved.
Condition  Neoplasms, Metastatic
Intervention  Procedure: Stereotactic Body Radiation Therapy
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Suspended
Enrollment  300
Start Date  April 2001
Completion Date April 2006
Eligibility Criteria 

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

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00178399
Organization ID URCC 9700
Secondary IDs ††
Study Sponsor  University of Rochester
Collaborators ††
Investigators 
Principal Investigator:     Paul Okunieff, MD     University of Rochester    
Information Provided By University of Rochester
Verification Date September 2006
First Received Date  September 12, 2005
Last Updated Date September 6, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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