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Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
Not Recruiting
Trial ID: NCT03422198
Purpose
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.
Official Title
Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
Stanford Investigator(s)
Elizabeth Kidd
Associate Professor of Radiation Oncology (Radiation Therapy)
Eligibility
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, with
one of the following combinations of stage and grade:
- Stage IA, grade 2, 3
- Stage IB, grades 1-3
- Stage II, grades 1-3
- 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
- Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks
Intervention(s):
radiation: Vaginal Cuff Brachytherapy
radiation: Short course vaginal cuff brachytherapy
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Akschy Peer
650-736-0792