A Prospective Evaluation of a Palliative Radio-Surgical Approach for the Treatment of Gynecologic Malignancies
PRIMARY OBJECTIVES:
I. The primary goal of this study is to estimate the rate of grade 3 or higher acute
toxicities observed during a 6 month period following CyberKnife radiosurgery for
gynecologic cancers.
II. To evaluate clinical response to radio-surgery for gynecologic tumors.
III. To assess general and site specific quality of life (using SF-12, FACT-En, FACT-O,
FACT-Cx or FACT-V) and to evaluate patient's level of pain.
SECONDARY OBJECTIVES:
I. As a secondary objective, toxicities during the 2 years following CyberKnife radiosurgery
will also be described.
OUTLINE:
Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
After completion of study treatment, patients are followed at 1, 3, 6, 12, 18 and 24 months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute toxicity rate
estimate the rate of grade 3 or higher acute toxicities observed during a 6 month period
Yes
Robert DeBernardo, MD
Principal Investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
CASE13808
NCT01079832
May 2009
May 2012
Name | Location |
---|---|
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |