This randomized clinical trial studies how well internal radiation therapy with or without magnetic resonance imaging (MRI) works in treating patients with gynecologic cancer. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Computer systems that allow doctors to create a 3-dimensional (3-D) picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed. Using a magnetic resonance (MR)-tracking device may improve the placement of the brachytherapy catheters.
Additional locations may be listed on ClinicalTrials.gov for NCT03277469.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Temporarily closed to accrual
Contact: Martin T. King
 Dana-Farber Cancer InstituteStatus: Temporarily closed to accrual
Contact: Martin T. King
 PRIMARY OBJECTIVE:
I. To compare brachytherapy treatment parameters, specifically V150 (target volume that receives 150% of the prescription dose) as a measure of dose heterogeneity, for patients treated with and without use of the MR-tracker when stratified by non-tandem-based versus (vs.) tandem-based template interstitial applicators.
SECONDARY OBJECTIVES:
I. Local tumor control following MR-based brachytherapy, defined by radiographic parameters or biopsy on routine follow-up at 2 and 5 years.
II. Documentation of radiographic parameters for correlative outcome study.
III. Clinical outcome including disease-free survival, overall survival and treatment-related toxicity at 2 and 5 years.
IV. Patient-reported quality of life (QOL) assessment at baseline, within 3 weeks before and/or after the brachytherapy procedure, and 1 year post treatment.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients undergo high-dose-rate (HDR) brachytherapy with MR-tracker.
ARM II: Patients undergo HDR brachytherapy without MR-tracker.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorMartin T. King