Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT03785288

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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