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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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month post treatment
Awards & highlights

SAVE 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.Check my eligibility
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.See study design
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.

SAVE Trial 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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My cancer is a specific type of endometrial carcinoma and may require a special radiation treatment.
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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).

SAVE Trial 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

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

SAVE 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
1,091 Previous Clinical Trials
1,732,374 Total Patients Enrolled
Cristina DeCesaris, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
David GaffneyPrincipal 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different places is this trial being run today?

"So far, 6 locations are running this trial. For example, MD Anderson in Houston, Stanford Cancer Center in Palo Alto, and Huntsman Cancer Institute/University of Utah in Maywood."

Answered by AI

Are new participants being sought for this clinical trial?

"This particular trial, as recorded on clinicaltrials.gov, is no longer looking for participants. The study was created on 1/30/2018 and last updated on 6/17/2022. There are 1111 other trials that are actively recruiting patients right now."

Answered by AI

Is it sanctioned by the FDA to give patients a short course of vaginal cuff brachytherapy?

"There is some evidence to suggest that Short course vaginal cuff brachytherapy is effective and safe, as it has progressed to a Phase 3 clinical trial."

Answered by AI
~57 spots leftby Nov 2026