Recurrent Ovarian Epithelial Cancer Clinical Trial
Official title:
A Phase I Study Evaluating the Efficacy and Toxicity of Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
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.
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