This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Undergo SBRT
Undergo FDG-PET/CT
Undergo FDG-PET/CT
Ancillary studies
Undergo FDG-PET/CT
Stanford University
Stanford, California, United States
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.
Time frame: At 3 months
The rate of grade 3 or greater non-hematologic acute toxicity as graded by the CTCAE v. 4.0
Toxicity will be tabulated by type and grade.
Time frame: 4-6 weeks, and up to 3 months after treatment
Measure CA-125 level
Time frame: At baseline; 6 weeks; and 3, 6, and 12 months
FACT-Ovarian Symptom Index
Time frame: At baseline; 6 weeks; and 3, 6, and 12 months
Late toxicity and non-grade 3 or greater acute toxicity following SBRT
Time frame: At 6 weeks; 3, 6, 12, 18 and 24 months
Local control
Time frame: Up to 5 years
Progression-free survival
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years
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