Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)
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 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.
Detailed description
Endometrial cancer is the most common gynecologic cancer in the Western world and primarily affects postmenopausal women. The primary form of treatment is surgery, consisting of a total abdominal or laparoscopic hysterectomy and bilateral salpingo-oophorectomy. Adjuvant radiotherapy for endometrial cancer has been studied in prospective trials for at least four decades. All trials have demonstrated an improvement in local regional control. However, improvement in survival has not been observed in prospective randomized trials in early-stage patients. There is great heterogeneity in prognoses in stage I patients. National Comprehensive Cancer Network (NCCN) guidelines consequently recommend no treatment in general for low-stage patients, adjuvant brachytherapy for patients with intermediate- and high-intermediate-risk disease, and for patients with deeply invasive tumors with high-grade lesions, external beam radiotherapy is an option (NCCN Guidelines 2016). Over the ensuing decades, there has been a shift toward increasing use of vaginal cuff brachytherapy. This is a phase III, unblinded, randomized trial comparing an experimental arm and a control arm of vaginal cuff brachytherapy: The experimental arm will treat subjects with 2 fractions of vaginal brachytherapy. The control arm will treat subjects with standard-of-care vaginal cuff brachytherapy of 3-5 fractions. Patients will be randomized 1:1 to the different treatment arms. After completion of cohort 1 (108 participants), the protocol was expanded to add a second cohort of 80 additional participants, and reopened study recruitment. Cohort 1 evaluated the non-inferiority of patient Health Related Quality of Life (HRQOL) in the experimental arm compared to the control arm using the Global Health Status from the EORTC QLQ-C30. Cohort 2 will 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.
Arms & interventions
- RadiationVaginal Cuff Brachytherapy
Undergo standard of care vaginal cuff brachytherapy
- RadiationShort course vaginal cuff brachytherapy
Undergo short course vaginal cuff brachytherapy
Outcome measures
Primary
Change in Quality of Life From Baseline to 1 Month
The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The questionnaire was given before and one month following treatment. The quality of life score ranges from 0-100, with higher scores indicating better quality of life. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.
Time frame: At 1 month post treatment
Cohort 2: Participant-Reported Financial Toxicity
One month post-brachytherapy, participants will be given the Functional Assessment of Chronic Illness Therapy (FACIT) - COmprehensive Score for financial Toxicity (COST) (FACIT-COST) questionnaire. The score range is 0-44, with higher scores indicating better financial well-being. Mean scores will be reported.
Time frame: One month after brachytherapy
Secondary
Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48
Time frame: one month post-treatment
USD Amount Charged for Procedures
Time frame: Approximately 6 months after treatment
Cohort 2: Participant-Reported Diet
Time frame: One month after brachytherapy
Cohort 2: Participant-Reported Activity Levels
Time frame: One month after brachytherapy
Cohort 2: Financial Toxicity Correlated With Quality of Life
Time frame: One month after brachytherapy
Eligibility criteria
Study locations (5)
Stanford Cancer Center
Palo Alto, California, 94304
Loyola University Medical Center
Maywood, Illinois, 60153
MD Anderson
Houston, Texas, 77030
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Intermountain Medical Center / LDS Hospital
Salt Lake City, Utah, 84143
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