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Vaginal Brachytherapy for Endometrial Cancer

This study is looking at two standard ways to treat early-stage endometrial cancer after surgery: HDR (high dose radiation) vaginal brachytherapy given as 7 Gy in 3 treatments, or HDR vaginal brachytherapy given as 4 Gy in 6 treatments. The main goal is to see how these treatments affect sexual function (measured by the Female Sexual Function Index or FSFI) and to understand patient preferences. You may be able to join if you are a woman aged 18 or older who has had a hysterectomy and bilateral salpingo-oophorectomy (removal of ovaries and fallopian tubes) with or without lymph node removal. The study plans to enroll 258 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 258 participants. You will be randomly assigned to one of two standard treatment groups, but you have the option to switch if you prefer.
What's involved
After surgery, you will receive radiation treatment within 4-12 weeks. You will also use a standard vaginal dilator after treatment and have follow-up appointments at 3 months, 1 year, and 2 years.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 2 years after treatment, with assessments at 3 months, 1 year, and 2 years.

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NCT03785288

Vaginal Cuff Brachytherapy Fractionation Study

Recruiting
PHASE3Ages 18+InterventionalTreatment
Kara Romano, MD
~258 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:HDR vaginal brachytherapy

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Female Sexual Function Index (FSFI)
Measured over 1 year
+1 more outcome measured

Conditions

Endometrial Cancer

Explore related trials

Endometrial Carcinoma

Where it's being run

3 sites across 3 states
Maryland1
New York1
Virginia1

Study leadership

  • Kara Romano, MD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Song Wood
[email protected]
434-243-0008
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 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

What this trial measures

  • Female Sexual Function Index (FSFI)1 year

    Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment

  • Preference Option Randomized Design (PORD)1 year

    Assessing the comparative effectiveness of receiving HDR vaginal brachytherapy on Arm B or Arm A for early stage endometrial cancer.