This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with ovarian or uterine cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03325634.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of stereotactic body radiation therapy (SBRT) for abdominopelvic recurrences in patients with ovarian and uterine serous carcinoma.
SECONDARY OBJECTIVES:
I. Determine the rates of one-year local control, progression-free survival, overall survival, chemotherapy-free interval, and to assess quality of life.
II. Determine the functional imaging correlates for local control and acute and late toxicities.
III. Determine the chronology and profile of the SBRT-associated immune response.
OUTLINE: This is dose escalation study followed by a dose-expansion study.
Patients undergo SBRT no more frequently than every other day for 3 fractions completed within 2 weeks. Patients also undergo collection of blood samples and computed tomography (CT) or positron emission tomography (PET) during screening and follow-up, and dynamic contrast-enhanced (DCE)-CT throughout the trial.
After completion of study treatment, patients are followed up at 6 weeks and then every 3 months for 1 year.
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorChristine Megan Fisher