Short Course Vaginal Cuff Brachytherapy in Treating Patients With Stage I-II Endometrial Cancer (SAVE)
Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Serous Adenocarcinoma
About this trial
This is an interventional treatment trial for Endometrial Clear Cell Adenocarcinoma
Eligibility 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, 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
- Patients 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
Sites / Locations
- Stanford Cancer Center
- Loyola University Medical Center
- MD Anderson
- Huntsman Cancer Institute/University of Utah
- Intermountain Medical Center / LDS Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Short course vaginal cuff brachytherapy
Vaginal cuff brachytherapy
Patients undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
Patients undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.