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Short Course Vaginal Cuff Brachytherapy for Endometrial Cancer

This study is testing if a shorter course of vaginal cuff brachytherapy (internal radiation therapy) works as well as the standard treatment for people with stage I or II endometrial cancer. Vaginal cuff brachytherapy uses radioactive material placed near the tumor in the upper part of the vagina to kill cancer cells. Researchers want to see if the shorter treatment is just as effective and how it impacts your quality of life and financial burden. You may be able to join if you have certain types of endometrial cancer (endometrioid, serous, or clear cell) that are stage I or II and your doctor recommends vaginal cuff brachytherapy. The study is currently recruiting participants.

Study design
This is a randomized phase III study comparing two different brachytherapy schedules. It plans to enroll 188 participants.
What's involved
You would undergo either standard of care vaginal cuff brachytherapy or short course vaginal cuff brachytherapy.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be measured one month after treatment, and financial toxicity will be measured one month after brachytherapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03422198

Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer

Recruiting
PHASE3All AgesInterventionalTreatment
University of Utah
~188 participants
Updated 2025-12-12 on ClinicalTrials.gov
What's tested:Vaginal Cuff BrachytherapyShort course vaginal cuff brachytherapy

At a glance

Recruiting sites
3 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Quality of Life From Baseline to 1 Month
Measured over At 1 month post treatment
+1 more outcome measured

Conditions

Endometrial Clear Cell Adenocarcinoma
Endometrial Endometrioid Adenocarcinoma
Endometrial Serous Adenocarcinoma
Stage I Uterine Corpus Cancer
Stage IA Uterine Corpus Cancer
Stage IB Uterine Corpus Cancer
Stage II Uterine Corpus Cancer
Uterine Corpus Carcinosarcoma
Uterine Corpus Sarcoma

Explore related trials

Endometrial CarcinomaEndometrial carcinosarcomaUterine Corpus Sarcoma

Where it's being run

5 sites across 4 states
Utah2
California1
Illinois1
Texas1

Study leadership

  • Cristina DeCesaris, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

Who to contact

Rachel Kingsford
[email protected]
801-585-0115
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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; Federation of Gynecology and Obstetrics (FIGO) stage I and stage II, with one of the following combinations of stage and grade:
Stage IA, grade 1 with LVSI, 2, 3
Stage IB, grades 1-3
Stage II, grades 1-3
Stage IIIA, grades 1-3, not receiving EBRT as part of adjuvant therapy.
Participants post-hysterectomy and free from residual disease.
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)-performance status 0-2.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Life expectancy of \>2 years.

Exclusion

Stages of endometrial carcinoma other than described.
Previous pelvic radiotherapy.
Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery.

What this trial measures

  • Change in Quality of Life From Baseline to 1 MonthAt 1 month post treatment

    The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The questionnaire was given before and one month following treatment. The quality of life score ranges from 0-100, with higher scores indicating better quality of life. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.

  • Cohort 2: Participant-Reported Financial ToxicityOne month after brachytherapy

    One month post-brachytherapy, participants will be given the Functional Assessment of Chronic Illness Therapy (FACIT) - COmprehensive Score for financial Toxicity (COST) (FACIT-COST) questionnaire. The score range is 0-44, with higher scores indicating better financial well-being. Mean scores will be reported.