NCT03422198RecruitingPhase 3
Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells. After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- First submitted
- 16 Jan 2018
- Start date
- 2 Feb 2018
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- University of Utah
- Diseases
- Endometrial cancer, Childhood cancers, Sarcoma
- NCT number
- NCT03422198
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 188
- From 2 Feb 2018 to the primary completion date, 30 Nov 2026
- 5 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
- Previous pelvic radiotherapy.
- Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.
Other
- Stages of endometrial carcinoma other than described.
Who the study is looking for
- Histologically confirmed endometrial carcinoma: endometrioid type, serous, and clear cell, to include tumors originating in the cervix, but are primarily located in the uterus, and for whom vaginal cuff brachytherapy is indicated. Carcinosarcoma and other sarcomas are permitted; Federation of Gynecology and Obstetrics (FIGO) stage I and stage II, with one of the following combinations of stage and grade:
- Stage IA, grade 1 with LVSI, 2, 3
- Stage IB, grades 1-3
- Stage II, grades 1-3
- Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
- Participants post-hysterectomy and free from residual disease.
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Life expectancy of \>2 years.
Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MD Anderson Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Recruiting |
| Stanford Cancer Center Coordinator of this site? Confirm its status | Palo Alto | United States | Completed |
| Intermountain Medical Center / LDS Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Completed |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.