Vaginal Cuff Brachytherapy for Uterine Cancer
(SAVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is vaginal cuff brachytherapy generally safe for humans?
Vaginal cuff brachytherapy is generally considered safe, with studies showing it results in excellent disease control and minimal toxicity for endometrial cancer. It has been found to cause less late toxicity compared to external beam radiation therapy, although there is a risk of vaginal stenosis (narrowing of the vagina) after treatment.12345
How is vaginal cuff brachytherapy different from other treatments for uterine cancer?
Vaginal cuff brachytherapy is unique because it delivers high-dose radiation directly to the site where the uterus was removed, minimizing exposure to surrounding tissues. This internal radiation therapy is often used after surgery to prevent cancer recurrence and can be administered in a shorter course compared to traditional external beam radiation, offering effective disease control with minimal side effects.13456
What data supports the effectiveness of the treatment Vaginal Cuff Brachytherapy for Uterine Cancer?
Research shows that vaginal cuff brachytherapy is effective in controlling disease with minimal side effects for early-stage endometrial cancer, and it is as effective as external beam radiation in preventing cancer recurrence. The SAVE trial's early results are promising, suggesting that a shorter treatment regimen may be a viable option.15678
Who Is on the Research Team?
Cristina DeCesaris
Principal Investigator
Huntsman Cancer Institute/ University of Utah
Are You a Good Fit for This Trial?
This trial is for patients with stage I-II endometrial cancer who have had a hysterectomy and no remaining disease. It's open to those with a life expectancy over 2 years, specific types of tumors (endometrioid, serous, clear cell), including carcinosarcoma. Participants must be able to consent and have an ECOG-performance status of 0-2.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo vaginal cuff brachytherapy. Arm I: Short course for 2 fractions with 1 week apart. Arm II: Standard of care for 3-5 fractions over no more than 3 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up visits occur at 1, 6, and 12 months.
What Are the Treatments Tested in This Trial?
Interventions
- Short course vaginal cuff brachytherapy
Short course vaginal cuff brachytherapy is already approved in European Union, United States, Canada for the following indications:
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Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor