NCT03785288RecruitingPhase 3
Vaginal Cuff Brachytherapy Fractionation Study
A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 258 (estimated)
- First submitted
- 15 Nov 2018
- Start date
- 17 Jan 2019
- Primary completion date
- 30 Jan 2027
- Lead sponsor
- Kara Romano, MD
- Diseases
- Endometrial cancer
- NCT number
- NCT03785288
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 258
- From 17 Jan 2019 to the primary completion date, 30 Jan 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Disease of more advanced stage (FIGO stage III-IV) or disease for which adjuvant external beam radiation therapy or chemotherapy is indicated
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland Medical Center (UMMC) Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.