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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 belowSelect...
I can take care of myself and perform daily activities.
Select...
My cancer is a specific type of endometrial carcinoma and may require a special radiation treatment.
Select...
I have had a hysterectomy and am free of any remaining cancer.
Select...
My gynecological cancer is in the early stage (stage I).
SAVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month after brachytherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month after brachytherapy
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 moreSAVE 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and perform daily activities.More than 16 weeks have passed since my hysterectomy.My cancer is a specific type of endometrial carcinoma and may require a special radiation treatment.My endometrial cancer is not in the specified stages.You are expected to live for more than 2 years.I have had a hysterectomy and am free of any remaining cancer.My gynecological cancer is in the early stage (stage I).I have had radiation therapy to my pelvic area before.
Research Study Groups:
This trial has the following groups:- Group 1: Short course vaginal cuff brachytherapy
- Group 2: Vaginal cuff brachytherapy
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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
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