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Brachytherapy

Vaginal Cuff Brachytherapy for Uterine Cancer (SAVE Trial)

Phase 3
Recruiting
Led By Cristina DeCesaris, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2
Patients post hysterectomy and free from residual disease
Must not have
Interval between the hysterectomy and planned start of radiotherapy exceeding 16 weeks
Previous pelvic radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month post treatment
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares short course vaginal cuff brachytherapy with standard of care vaginal cuff brachytherapy in treating patients with stage I-II endometrial cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort or pain at the treatment site, fatigue, skin changes in treated area, bladder symptoms like frequency or urgency, bowel symptoms such as diarrhea or rectal bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I have had a hysterectomy and am free of any remaining cancer.
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My gynecological cancer is in the early stage (stage I).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
More than 16 weeks have passed since my hysterectomy.
Select...
I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month after brachytherapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month after brachytherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Quality of Life From Baseline to 1 Month
Cohort 2: Participant-Reported Financial Toxicity
Secondary study objectives
Cohort 2: Financial Toxicity Correlated With Quality of Life
Cohort 2: Participant-Reported Activity Levels
Cohort 2: Participant-Reported Diet
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,433 Total Patients Enrolled
Cristina DeCesaris, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
David GaffneyPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
David Gaffney, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Media Library

Short course vaginal cuff brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03422198 — Phase 3
Uterine Corpus Cancer Research Study Groups: Short course vaginal cuff brachytherapy, Vaginal cuff brachytherapy
Uterine Corpus Cancer Clinical Trial 2023: Short course vaginal cuff brachytherapy Highlights & Side Effects. Trial Name: NCT03422198 — Phase 3
Short course vaginal cuff brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03422198 — Phase 3
~41 spots leftby Nov 2026
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