Short Course Vaginal Cuff Brachytherapy in Treating Patients with Stage I-II Endometrial Cancer
- 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 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
- Stages of endometrial carcinoma other than described
- Previous pelvic radiotherapy
- Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks
Salt Lake City
I. Evaluate the non-inferiority of patient health related quality of life (HRQOL) using the Global Health Status from the Quality of Life Questionnaire Core 30 (QLQ-C30) in the 2 arms one month after treatment.
I. Compare treatment-related symptoms on HRQOL using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), question 48 between the two treatment arms.
II. Compare cost effectiveness between the two treatment arms.
I. Report vaginal, bowel, and bladder symptoms on HRQOL using the EORTC EN24 the two treatment arms.
II. Evaluate toxicities between the two treatment arms.
III. Compare local recurrence and document patterns of recurrence between the two treatment arms.
IV. Evaluate and compare doses to organs at risk (bladder, rectum, sigmoid colon, and urethra) and the prescribed target in the two arms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
ARM II: Patients undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
After completion of study treatment, patients are followed up at 1, 6, 12, 24, and 36 months.
Trial Phase Phase III
Trial Type Treatment
Huntsman Cancer Institute / University of Utah
David K. Gaffney
- Primary ID HCI103841
- Secondary IDs NCI-2018-00011
- Clinicaltrials.gov ID NCT03422198