A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer
Summary
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.
Detailed description
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.
Arms & interventions
- RadiationHDR vaginal brachytherapy
HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
Outcome measures
Primary
Female 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
Secondary
Vaginal Length Measurement
Time frame: 1 year
Vaginal Length Measurement
Time frame: 2 years
Eligibility criteria
Study locations (3)
University of Maryland Medical Center (UMMC)
Baltimore, Maryland, 21201
SUNY Upstate Medical University
Syracuse, New York, 13210
University of Virginia
Charlottesville, Virginia, 22903