A Phase I Study Evaluating the Efficacy and Toxicity of Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
I. Evaluate response of platinum-resistant ovarian cancer to stereotactic body radiation
therapy (SBRT) using fludeoxyglucose F 18 (18F-FDG) positron emission tomography
(PET)/computed tomography (CT) 3 months after therapy.
II. Determine the rate of grade 3 or greater non-hematologic acute toxicity from SBRT using
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
I. Evaluate response to SBRT using cancer antigen-125 (CA-125) and symptom assessment using
Functional Assessment of Cancer Therapy (FACT)-Ovarian Symptom Index (FOSI).
II. Determine the rate of late and non-grade 3 acute toxicity using CTCAE version 4.0.
III. Evaluate local control, progression-free survival, and overall survival following SBRT.
Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks, 3, 6, 9, and 12
months, and then every 6 months for 4 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response to SBRT as assessed by FDG-PET/CT
FDG-PET response based on interpretation by nuclear medicine physician with measurement of the maximal standard uptake value (SUV) and identification of new sites of disease. Percentage of decreased SUVmax between the pre- and post-treatment FDG-PET/CT, evaluating means, medians, range and standard deviations.
At 3 months
United States: Institutional Review Board
|Stanford University||Stanford, California 94305|