The purpose of this study is to see the effects of two different standard of care treatments of endometrial cancer on sexual dysfunction. This study will compare two standard of care treatments: HDR (high dose radiation) vaginal brachytherapy 3 fractions of 7 Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.
Patients are randomized to HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at 5mm. Radiation delivered 4-12 weeks after surgery OR HDR vaginal brachytherapy 4Gy in 6 fractions prescribed at the cylinder surface. Patients have the option to request to decline their randomization and switch to the alternate treatment ARM if they prefer. Radiation delivered 4-12 weeks after surgery. Participants in all Arms will receive standard vaginal dilator for use after treatment (to promote healing). 3 month, 1 year and 2 year follow up assessments are performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
University of Maryland Medical Center (UMMC)
Baltimore, Maryland, United States
RECRUITINGSUNY Upstate Medical University
Syracuse, New York, United States
RECRUITINGUniversity of Virginia
Charlottesville, Virginia, United States
RECRUITINGFemale Sexual Function Index (FSFI)
Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment
Time frame: 1 year
Preference Option Randomized Design (PORD)
Assessing the comparative effectiveness of receiving HDR vaginal brachytherapy on Arm B or Arm A for early stage endometrial cancer.
Time frame: 1 year
Vaginal Length Measurement
Using vaginal dilator compare patient vaginal measurement 1 year after completion of treatment
Time frame: 1 year
Vaginal Length Measurement
Using vaginal dilator compare patient vaginal measurement 2 years after completion of treatment
Time frame: 2 years
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