Short course vaginal cuff brachytherapy for early-stage endometrial cancer
Official title: Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
Run by University of Utah · NCT03422198 · Data updated 2026-11-12
This study is testing if a shorter type of radiation treatment for early-stage endometrial cancer is just as effective as the standard longer treatment, while also looking at how it affects patients' quality of life and other factors.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 188 (estimated) |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Palo Alto, California and 4 other locations) |
| Status | Recruiting · results posted |
| Started | February 2, 2018 |
| Main results expected | November 30, 2026 |
| Study ends | October 31, 2029 |
| Registry record updated | December 12, 2025 |
| Trial ID | NCT03422198 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with histologically confirmed stage I-II endometrial carcinoma who have undergone a hysterectomy and are free from residual disease.
✕Probably not a fit
Patients with stages of endometrial carcinoma other than those specified or those with previous pelvic radiation therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase III trial evaluates the effectiveness of short course vaginal cuff brachytherapy compared to standard care in treating stage I-II endometrial cancer. Participants are randomized into two groups: one receiving the short course treatment and the other receiving the standard treatment over a longer duration. The study aims to assess health-related quality of life, treatment-related symptoms, cost-effectiveness, and patterns of recurrence. It also evaluates the impact on organs at risk and the total distance traveled for treatment visits.
Why it matters
Potential benefit: If successful, this approach could provide a more efficient and effective treatment option for patients with early-stage endometrial cancer.
How similar studies have gone: Other studies have shown promise with similar brachytherapy approaches, but this specific short course method is being evaluated for its unique benefits.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Stages of endometrial carcinoma other than described. * Previous pelvic radiotherapy. * Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.
Where it's running
-
Loyola University Medical Center
Maywood, Illinois, United States Recruiting -
MD Anderson
Houston, Texas, United States Recruiting -
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States Recruiting -
Stanford Cancer Center
Palo Alto, California, United States Completed -
Intermountain Medical Center / LDS Hospital
Salt Lake City, Utah, United States Completed
Study contacts
- Principal investigator: Cristina DeCesaris, MD — Huntsman Cancer Institute
- Study coordinator: Rachel Kingsford
- Email: Rachel.Kingsford@hci.utah.edu
- Phone: 801-585-0115
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing if blood tests can help predict if endometrial cancer will come back by looking for cancer cells and genetic changes in patients during their treatment.
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This study is testing if adding ipilimumab to nivolumab can help people with recurrent endometrial cancer live longer and feel better compared to just using nivolumab alone.
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Progestins before surgery for endometrial cancer or precancers
This phase II study tests two progestin options (megestrol acetate vs. micronized progesterone) for women with endometrial cancer or atypical endometrial hyperplasia before they have surgery.
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Combining ONC201 and Atezolizumab for treating obesity-related endometrial cancer
This study is testing a new treatment for advanced or recurrent endometrial cancer in obese women by combining two drugs, ONC201 and atezolizumab, to see if it helps manage their cancer better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.