Ovarian Cancer Clinical Trial
Short Course Vaginal Cuff Brachytherapy in Treating Patients With Stage I-II Endometrial Cancer
Summary
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-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.
Full Description
PRIMARY OBJECTIVES:
I. Evaluate the non-inferiority of patient health related quality of life (HRQOL) using the Global Health Score from the Quality of Life Questionnaire Core 30 (QLQ-C30) in the 2 arms one month after treatment.
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.
II. Compare cost effectiveness between the two treatment arms.
TERTIARY OBJECTIVES:
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. There will be two analyses: A single interim evaluation of patterns of recurrence will be performed after a minimum of 75 patients have been accrued, and the second evaluation will be performed at the end of the study.
IV. Evaluate and compare doses to organs at risk (bladder, rectum, sigmoid colon, and urethra) and the prescribed target in the two arms.
V. Compare total distance traveled to the cancer center for study related visits.
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, and 12 months.
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
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There are 5 Locations for this study
Palo Alto California, 94304, United States
Maywood Illinois, 60153, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84143, United States
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