Endometrial CancerPhase 3NCT03785288
Vaginal Cuff Brachytherapy Fractionation Study
A Phase 3 study testing HDR vaginal brachytherapy in people with Endometrial Cancer, run by Kara Romano, MD at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- HDR vaginal brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jan 2019to 30 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Maryland Medical Center (UMMC)
Baltimore, Maryland, 21201
Caitlin Eggleston, 410-328-7586, caitlineggleston@umm.edu
Sarah McAvoy, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Kara Romano, MD, KED7C@uvahealth.org
Song Wood, UVARADONCClinicalTrials@uvahealth.org
- Recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
Erin Bingham, 315-464-3603, BinghamE@upstate.edu
Lindsay Noah-Vermillion, noahverl@upstate.edu
About this study
Official title: A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer
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.
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- HDR vaginal brachytherapy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDR vaginal brachytherapyRadiation
HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
| Study group | Role | What they receive |
|---|---|---|
| ARM A: 3 treatments of 7Gy | Active comparator | Arm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy Receives: Radiation: HDR vaginal brachytherapy |
| ARM B: 6 treatment of 4Gy | Active comparator | Arm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy Receives: Radiation: HDR vaginal brachytherapy |
| ARM AB: 6 treatment of 4Gy | Active comparator | 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 Receives: Radiation: HDR vaginal brachytherapy |
| ARM BA: 3 treatments of 7Gy | Active comparator | 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 Receives: Radiation: HDR vaginal brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI)
Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment
Measured: 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.
Measured: 1 year
Secondary outcomes (2)
Vaginal Length Measurement
Using vaginal dilator compare patient vaginal measurement 1 year after completion of treatment
Measured: 1 year
Vaginal Length Measurement
Using vaginal dilator compare patient vaginal measurement 2 years after completion of treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start17 Jan 2019
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will compare two standard of care treatments: HDR vaginal brachytherapy 3 fractions of 7Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kara Romano, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kara Romano, MD, University of Virginia
- Investigators
- Kara Romano, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785288
- Sponsor's protocol ID
- 21063
- Status last verified
- Apr 2026
- First submitted
- 15 Nov 2018
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03785288
- Acronym / sponsor ID
- 21063
- Conditions
- Endometrial Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Kara Romano, MDUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study will compare two standard of care treatments: HDR vaginal brachytherapy 3 fractions of 7Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.
| Arm | Type | Receives |
|---|---|---|
| ARM A: 3 treatments of 7Gy | Active comparator | Radiation: HDR vaginal brachytherapyArm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy |
| ARM B: 6 treatment of 4Gy | Active comparator | Radiation: HDR vaginal brachytherapyArm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy |
| ARM AB: 6 treatment of 4Gy | Active comparator | Radiation: HDR vaginal brachytherapyArm 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 |
| ARM BA: 3 treatments of 7Gy | Active comparator | Radiation: HDR vaginal brachytherapyinitially 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDR vaginal brachytherapyHDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions | Radiation | ARM A: 3 treatments of 7Gy, ARM AB: 6 treatment of 4Gy, ARM B: 6 treatment of 4Gy, ARM BA: 3 treatments of 7Gy |
Primary outcome
Female Sexual Function Index (FSFI)
Time frame: 1 year
Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment
Preference Option Randomized Design (PORD)
Time frame: 1 year
Assessing the comparative effectiveness of receiving HDR vaginal brachytherapy on Arm B or Arm A for early stage endometrial cancer.
2 secondary outcomes
Vaginal Length Measurement
Time frame: 1 year
Vaginal Length Measurement
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kara Romano, MD principal investigator
University of Virginia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HDR vaginal brachytherapy in people with Endometrial Cancer, run by Kara Romano, MD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Song Wood (434-243-0008, UVARADONCClinicalTrials@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.