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Short Course Vaginal Cuff Brachytherapy in Treating Patients with Stage I-IIIA Endometrial Cancer
Trial Status: active
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 patients with stage I-IIIA 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.
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 and stage II, with one of the following combinations of stage and grade:
* Stage IA, grade 1 with lymphatic invasion (LVSI), 2, 3
* Stage IB, grades 1-3
* Stage II, grades 1-3
* Stage IIIA, grades 1-3, not receiving external beam radiation therapy (EBRT) as part of adjuvant therapy
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03422198.
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. (Cohort 1)
II. To evaluate the frequency and severity of patient-reported financial toxicity in patients with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one-month post-VCB. (Cohort 2)
SECONDARY OBJECTIVES:
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. (Cohort 1)
II. Compare cost effectiveness between the two treatment arms. (Cohort 1)
EXPLORATORY OBJECTIVES:
I. Report vaginal, bowel, and bladder symptoms on HRQOL using the EORTC EN24 the two treatment arms. (Cohort 1)
II. Evaluate toxicities between the two treatment arms. (Cohort 1)
III. Compare local recurrence and document patterns of recurrence between the two treatment arms. (Cohort 1)
IV. Evaluate and compare doses to organs at risk (bladder, rectum, sigmoid colon, and urethra) and the prescribed target in the two arms. (Cohort 1)
V. Compare total distance traveled to the cancer center for study related visits. (Cohort 1)
VI. Exploratory objectives will include evaluation of differences in patient-reported financial toxicity to assess any impact of treatment duration on outcomes. (Cohort 2)
VII. Evaluation of patient-reported diet and physical activity levels and quality of life in patients with early-stage endometrial cancer treated with vaginal cuff-brachytherapy (VCB) at one-month post-VCB. (Cohort 2)
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 PhasePhase III
Trial Typetreatment
Lead OrganizationHuntsman Cancer Institute/University of Utah
