Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer

Not Recruiting

Trial ID: NCT03422198


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
Elizabeth Kidd

Associate Professor of Radiation Oncology (Radiation Therapy)


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


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

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