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Endometrial Clear Cell AdenocarcinomaCancerRadiationPhase 3

What this study is

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.

What's being tested

  • Vaginal Cuff Brachytherapy

    Intervention · RADIATION

    Undergo standard of care vaginal cuff brachytherapy

  • Short course vaginal cuff brachytherapy

    Intervention · RADIATION

    Undergo short course vaginal cuff brachytherapy

Study details

Official title
Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
Sponsor
University of Utah
Conditions
Endometrial Clear Cell Adenocarcinoma · Endometrial Endometrioid Adenocarcinoma · Endometrial Serous Adenocarcinoma · Stage I Uterine Corpus Cancer · Stage IA Uterine Corpus Cancer · Stage IB Uterine Corpus Cancer · Stage II Uterine Corpus Cancer · Uterine Corpus Carcinosarcoma · Uterine Corpus Sarcoma
Enrolling
188 people
Starts
2018-02-02
Est. completion
2029-10-31
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗