Actively Recruiting
Vaginal Cuff Brachytherapy Fractionation Study
Led by Kara Romano, MD · Updated on 2026-04-22
258
Participants Needed
3
Research Sites
471 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vaginal Cuff Brachytherapy Fractionation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and follow the study protocol
- Surgery with Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo Oophorectomy, with or without lymph node dissection
- Pathologically confirmed FIGO Stage I-II (grade 1-3) endometrioid endometrial cancer, including serous, clear cell, and carcinosarcoma subtypes
- No measurable disease after surgery
- ECOG Performance Status between 0 and 2
- Age 18 years or older
- Life expectancy of at least 12 months
You will not qualify if you...
- Advanced stage disease (FIGO Stage III-IV) or needing external beam radiation or chemotherapy
- History of prior pelvic radiation therapy or planned additional pelvic radiation
- Not recovered from side effects of previous treatments given within 4 weeks before study start
- More than 14 weeks between surgery and starting radiation unless receiving chemotherapy (radiation allowed within 6 months if chemotherapy given)
- Receiving investigational agents currently or within 30 days prior to study
- Unable or unwilling to participate in study procedures
- Pregnant or breastfeeding
- Prisoner status
- Serious uncontrolled medical conditions affecting ability to receive study treatment
- History of central nervous system diseases such as uncontrolled seizures, brain tumors, brain metastases, recent stroke, transient ischemic attack, or subarachnoid hemorrhage within 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University of Maryland Medical Center (UMMC)
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
3
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
S
Song Wood
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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