Vaginal Cuff Brachytherapy for Uterine Cancer
(SAVE Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Utah
Disqualifiers: Other cancer stages, Previous pelvic radiotherapy, Long interval post-hysterectomy
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
15678How 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.
13578Eligibility Criteria
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
I can take care of myself and perform daily activities.
My cancer is a specific type of endometrial carcinoma and may require a special radiation treatment.
You are expected to live for more than 2 years.
+3 more
Exclusion Criteria
More than 16 weeks have passed since my hysterectomy.
My endometrial cancer is not in the specified stages.
I have had radiation therapy to my pelvic area before.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
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.
2-3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up visits occur at 1, 6, and 12 months.
12 months
3 visits (in-person)
Participant Groups
The study compares short course vaginal cuff brachytherapy—a type of internal radiation therapy given over a shorter period—with the standard treatment duration. The goal is to see which method works better for treating upper vagina tumors in endometrial cancer patients.
2Treatment groups
Experimental Treatment
Active Control
Group I: Short course vaginal cuff brachytherapyExperimental Treatment1 Intervention
Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
Group II: Vaginal cuff brachytherapyActive Control1 Intervention
Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
Short course vaginal cuff brachytherapy is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Vaginal Cuff Brachytherapy for:
- Endometrial cancer
- Uterine cancer
- Vaginal cancer
🇺🇸 Approved in United States as Vaginal Cuff Brachytherapy for:
- Endometrial cancer
- Uterine cancer
- Vaginal cancer
🇨🇦 Approved in Canada as Vaginal Cuff Brachytherapy for:
- Endometrial cancer
- Uterine cancer
- Vaginal cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD AndersonHouston, TX
Intermountain Healthcare / LDS HospitalSalt Lake City, UT
Huntsman Cancer Institute/University of UtahSalt Lake City, UT
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Who Is Running the Clinical Trial?
University of UtahLead Sponsor
References
Vaginal cuff brachytherapy for endometrial cancer: a review of major clinical trials with a focus on fractionation. [2022]The use of vaginal cuff brachytherapy in the adjuvant management of endometrial cancer has increased over time. Recommendations from the American Brachytherapy Society, American Society of Radiation Oncology, and European Society for Medical Oncology help to guide the application of vaginal cuff brachytherapy. However, wide variation in practice remains regarding treatment techniques. This article reviews the use of vaginal cuff brachytherapy in the post-operative management of endometrial cancer. It covers risk stratification, treatment rationale, outcomes, and treatment planning recommendations with a specific focus on dose-fractionation regimens. The authors performed a thorough literature review of articles pertinent to the goals of this review. Also presented are early results of the Short Course Adjuvant Vaginal Cuff Brachytherapy in Early Endometrial Cancer Compared with Standard of Care (SAVE) trial of a two-fraction vaginal cuff brachytherapy regimen.Adjuvant vaginal cuff brachytherapy for early-stage endometrial cancer results in excellent disease control with minimal toxicity. The PORTEC-2 trial showed that vaginal cuff brachytherapy is non-inferior to external beam radiation for vaginal recurrence in patients at high-intermediate risk. Vaginal cuff brachytherapy may also be used as a boost following external beam radiation in combination with chemotherapy for high-risk histologies. Numerous techniques can be used for vaginal cuff brachytherapy, including various medical devices, dose-fractionation schedules, and treatment planning approaches. The early control results of the SAVE trial are promising and we are hopeful that this trial establishes two fraction regimens as a viable option for vaginal cuff brachytherapy.
Time-driven activity-based costing of adjuvant vaginal cuff brachytherapy for uterine cancer in an integrated brachytherapy suite. [2022]Adjuvant vaginal cuff brachytherapy is well tolerated and reduces the risk of local recurrence in endometrial cancer. However, there is provider variation in the number of radiation treatments, which ranges from three to six fractions. Using time-driven activity-based costing, we calculated the cost to deliver three vs six fractions to determine the value of each regimen at our brachytherapy suite with CT-on-rails.
Phase III Trial: Adjuvant Pelvic Radiation Therapy Versus Vaginal Brachytherapy Plus Paclitaxel/Carboplatin in High-Intermediate and High-Risk Early Stage Endometrial Cancer. [2022]The primary objective was to determine if vaginal cuff brachytherapy and chemotherapy (VCB/C) increases recurrence-free survival (RFS) compared with pelvic radiation therapy (RT) in high-intermediate and high-risk early-stage endometrial carcinoma.
The role for vaginal cuff brachytherapy boost after external beam radiation therapy in endometrial cancer. [2022]To evaluate the role and technique of a vaginal cuff brachytherapy (VB) boost to adjuvant external beam (EB) radiation for endometrial cancer through a systematic review.
Predictors of vaginal stenosis after intravaginal high-dose-rate brachytherapy for endometrial carcinoma. [2022]Intravaginal high-dose-rate brachytherapy is an effective adjuvant treatment for localized endometrial carcinoma. However, relatively little is known about risk factors of post-treatment vaginal stenosis (VS).
Vaginal cuff brachytherapy in endometrial cancer - a technically easy treatment? [2020]Endometrial cancer (EC) is one of the most common gynecological cancers among women in the developed countries. Vaginal cuff is the main location of relapses after a curative surgical procedure and postoperative radiation therapy have proven to diminish it. Nevertheless, these results have not translated into better survival results. The preeminent place of vaginal cuff brachytherapy (VCB) in the postoperative treatment of high- to intermediate-risk EC was given by the PORTEC-2 trial, which demonstrated a similar reduction in relapses with VCB than with external beam radiotherapy (EBRT), but VCB induced less late toxicity. As a result of this trial, the use of VCB has increased in clinical practice at the expense of EBRT. A majority of the clinical reviews of VCB usually address the risk categories and patient selection but pay little attention to technical aspects of the VCB procedure. Our review aimed to address both aspects. First of all, we described the risk groups, which guide patient selection for VCB in clinical practice. Then, we depicted several technical aspects that might influence dose deposition and toxicity. Bladder distension and rectal distension as well as applicator position or patient position are some of those variables that we reviewed.
A new short daily brachytherapy schedule in postoperative endometrial carcinoma. Preliminary results. [2022]To evaluate the preliminary results of vaginal-cuff relapses (VCR) and complications of a short brachytherapy (BT) schedule in postoperative endometrial carcinoma.
The design of a novel direction modulated brachytherapy vaginal cylinder applicator for optimizing coverage of the apex. [2022]High-dose-rate (HDR) vaginal cuff brachytherapy is an effective adjuvant therapy for women with stage I endometrial cancer. Although infrequent, failures do occur, most frequently at the vaginal vault. A potential cause of failure is insufficient dosimetric coverage at the vaginal apex due to cold spots from the anisotropic dose distribution of the source. Here, we propose a novel direction modulated brachytherapy (DMBT)-concept vaginal cylinder (VC) applicator that resolves this dosimetric issue.