Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
University of Utah
Summary
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.
Description
Endometrial cancer is the most common gynecologic cancer in the Western world and primarily affects postmenopausal women. The primary form of treatment is surgery, consisting of a total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. Adjuvant radiotherapy for endometrial cancer has been studied in prospective trials for at least four decades. All trials have demonstrated an improvement in local regional control. However, improvement in survival has not been observed in prospective randomized trials in early-stage patients. There is great heterogeneity in prognoses…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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. * Pa…
Interventions
- RadiationVaginal Cuff Brachytherapy
Undergo standard of care vaginal cuff brachytherapy
- RadiationShort course vaginal cuff brachytherapy
Undergo short course vaginal cuff brachytherapy
Locations (5)
- Stanford Cancer CenterPalo Alto, California
- Loyola University Medical CenterMaywood, Illinois
- MD AndersonHouston, Texas
- Huntsman Cancer Institute/University of UtahSalt Lake City, Utah
- Intermountain Medical Center / LDS HospitalSalt Lake City, Utah