A Study For Using Radiosurgery On Limited Metastases
|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.
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|