A Study For Using Radiosurgery On Limited Metastases
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|ClinicalTrials.gov Identifier: NCT00178399|
Recruitment Status : Suspended (to analyze data of subjects already enrolled.)
First Posted : September 15, 2005
Last Update Posted : May 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms, Metastatic||Procedure: Stereotactic Body Radiation Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study For Using Radiosurgery On Limited Metastases|
|Study Start Date :||April 2001|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
|Experimental: Stereotactic body radiation therapy||Procedure: Stereotactic Body Radiation Therapy|
- To determine the feasibility and potential utility of radiosurgery for limited metastatic disease, compared to historical controls. [ Time Frame: From the date of radiation therapy treatment to the date of first failure or date of death from any cause whichever came first, assessed up to 20 years. ]Time to progression.
- Quality of life and correlation with pro-apoptotic, inflammatory, and anabolic cytokine profiles [ Time Frame: 30 months from date of registration. ]Correlation of data from QOL questionnaires and blood markers.
- Analyze impact of disease bulk and number of sites involved. [ Time Frame: From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years ]Analysis or response and progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178399
|United States, New York|
|University of Rochester Department of Radiation Oncology|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Michael Milano, MD PhD||University of Rochester|