Recruiting
Phase 3

HDR vs. HDR

Sponsor:

Kara Romano, MD

Code:

NCT03785288

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HDR vaginal brachytherapy

Study Details

Brief 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.

Conditions

Endometrial Cancer

Study ID

NCT03785288

Start date

Jan 17, 2019

Status verified date

Apr, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator.
  • Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo Oophorectomy (TH-BSO) with or without lymph node dissection.
  • Subject must have FIGO Stage I-II (grade 1-3) pathologically proven (histologic) endometrioid cancer, including all subtypes. Serous, clear cell, and carcinosarcoma histologic pathologies are allowed.
  • Subjects must have no measurable disease after surgery.
  • ECOG Performance Status of 0-2
  • Age ≥ 18 years
  • Subject must have a life expectancy ≥ 12 months

Exclusion Criteria:

  • Disease of more advanced stage (FIGO stage III-IV) or disease for which adjuvant external beam radiation therapy or chemotherapy is indicated
  • Patients with a history of prior pelvic radiation therapy or if additional pelvic radiation therapy is planned
  • Subjects who have not recovered from side effects of agents administered more than 4 weeks prior to the on-study date
  • Subjects that require > 14 weeks between surgery and initiation of radiation therapy on study unless the subject is receiving chemotherapy. Subjects receiving chemotherapy may have radiation therapy initiated within 6 months after surgery.

\* Subjects who do not meet this criteria may still be eligible. The UVA Coordinating Center and Overall Study PI will review each case and inform the site of the approval decision.
  • Subjects who are receiving any investigational agents or have had any investigational agent within the 30 days prior to the on-study date
  • Subject is unable or unwilling to participate in a study-related procedure
  • Pregnant and breastfeeding women are excluded from this study
  • Subject is a prisoner
  • A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.
  • Subjects with a history of evidence upon physical examination of central nervous system disease including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (stroke), transient ischemic attack, or subarachnoid hemorrhage within six months of study entry

Study Design

Enrollment

258 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: ARM A: 3 treatments of 7Gy

Arm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy

active comparator: ARM B: 6 treatment of 4Gy

Arm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy

active comparator: ARM AB: 6 treatment of 4Gy

Arm AB: initially randomized to ARM A but wanted to switch to ARM B treatment of HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy

active comparator: ARM BA: 3 treatments of 7Gy

initially randomized to ARM B but wanted to switch to ARM A of HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy

Interventions

HDR vaginal brachytherapy

HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions

Primary outcome measure

  • Female Sexual Function Index (FSFI) [ Time Frame: 1 year ]
  • Preference Option Randomized Design (PORD) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Song Wood

434-243-0008UVARADONCClinicalTrials@uvahealth.org

Locations

University of Maryland Medical Center (UMMC)

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Caitlin Eggleston

410-328-7586caitlineggleston@umm.edu

Principal Investigator:

Sarah McAvoy, MD

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Erin Bingham

315-464-3603BinghamE@upstate.edu

Lindsay Noah-Vermillion

noahverl@upstate.edu

Principal Investigator:

Brittany Simone, DO

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Kara Romano, MD

KED7C@uvahealth.org

Song Wood

UVARADONCClinicalTrials@uvahealth.org

Principal Investigator:

Kara Romano, MD

More Information

Sponsor

Kara Romano, MD

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kara Romano, MD on 2026-04-22.