Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium.
Sergio Pecorelli
https://pubmed.ncbi.nlm.nih.gov/19367689Actively Recruiting
Phase 3
All Genders
ID03422198
Short Course Adjuvant Vaginal Cuff Brachytherapy in Early Endometrial Cancer Compared to Standard of Care
Led by University of Utah · Updated on 2025-12-12
188
Participants Needed
5
Research Sites
152 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
H
Huntsman Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating short course vaginal cuff brachytherapy compared with the standard care of vaginal cuff brachytherapy in participants with stage I-II endometrial cancer. This phase III randomized trial aims to see how well the shorter treatment works and to assess its impact on patient quality of life and financial burden. The study was expanded after initial recruitment to include additional participants and monitor financial toxicity alongside quality of life outcomes. The trial compares two treatment groups: one group receives short course vaginal cuff brachytherapy with 2 fractions spaced 1 week apart, while the other group receives the standard of care with 3 to 5 fractions over no more than 3 weeks. Both treatments involve placing radioactive material directly into or near the upper vagina to target cancer cells after surgery. Participants are closely monitored during and after treatment, with assessments of quality of life, treatment-related symptoms, diet, and activity levels. Financial toxicity and costs related to procedures are also evaluated. Outcome measures include changes in quality of life and patient-reported financial impact at one month post-treatment. The study continues until 2029, with ongoing recruitment and follow-up.
CONDITIONS
Brief Title
Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed endometrial carcinoma of endometrioid, serous, clear cell, carcinosarcoma, or other sarcoma types
- Federation of Gynecology and Obstetrics (FIGO) stage I or stage II with specific stage and grade combinations
- Stage IA, grade 1 with lymphovascular space invasion (LVSI) grades 2 or 3
- Stage IB, grades 1 to 3
- Stage II, grades 1 to 3
- Stage IIIA, grades 1 to 3, not receiving external beam radiation therapy (EBRT) as adjuvant therapy
- Post-hysterectomy with no residual disease
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Able to provide informed consent and willing to sign approved consent form
- Life expectancy greater than 2 years
You will not qualify if you...
- Endometrial carcinoma stages other than those specified in inclusion criteria
- Previous pelvic radiation therapy
- Concurrent malignancy requiring non-protocol anti-cancer treatment other than surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 weeks
Participants receive either short course vaginal cuff brachytherapy (2 fractions spaced 1 week apart) or standard vaginal cuff brachytherapy (3-5 fractions over no more than 3 weeks).
Multiple treatment visits depending on assigned brachytherapy schedule
Follow-up
Duration - Up to 6 months
Participants are monitored for quality of life, treatment-related symptoms, and financial toxicity up to 6 months after treatment.
1 visit at 1 month post-treatment and 1 visit approximately 6 months after treatment
Trial Site Locations
Total: 5 locations
1
Stanford Cancer Center
Palo Alto, California, United States, 94304
Completed
2
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
3
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
4
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
5
Intermountain Medical Center / LDS Hospital
Salt Lake City, Utah, United States, 84143
Completed
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Research Team
R
Rachel Kingsford
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Lymphvascular space involvement: an independent prognostic factor in endometrial cancer.
Justine M Briët, Harry Hollema, Nathalie Reesink...
https://pubmed.ncbi.nlm.nih.gov/15721428Should the presence of lymphvascular space involvement be used to assign patients to adjuvant therapy following hysterectomy for unstaged endometrial cancer?
David E Cohn, Neil S Horowitz, David G Mutch...
https://pubmed.ncbi.nlm.nih.gov/12468320A role for adjuvant radiation in clinically early carcinoma of the endometrium?
Gillian Monica Thomas
https://pubmed.ncbi.nlm.nih.gov/20975365Substantial lymph-vascular space invasion (LVSI) is a significant risk factor for recurrence in endometrial cancer--A pooled analysis of PORTEC 1 and 2 trials.
Tjalling Bosse, Elke E M Peters, Carien L Creutzberg...
https://pubmed.ncbi.nlm.nih.gov/26049688Frequency and effect of adjuvant radiation therapy among women with stage I endometrial adenocarcinoma.
Christopher M Lee, Aniko Szabo, Dennis C Shrieve...
https://pubmed.ncbi.nlm.nih.gov/16434629Posttraumatic stress disorder after high-dose-rate brachytherapy for cervical cancer with 2 fractions in 1 application under spinal/epidural anesthesia: incidence and risk factors.
Kathrin Kirchheiner, Agnieszka Czajka-Pepl, Elisabeth Ponocny-Seliger...
https://pubmed.ncbi.nlm.nih.gov/24721589Postoperative external irradiation and prognostic parameters in stage I endometrial carcinoma: clinical and histopathologic study of 540 patients.
J Aalders, V Abeler, P Kolstad...
https://pubmed.ncbi.nlm.nih.gov/6999399Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma: multicentre randomised trial. PORTEC Study Group. Post Operative Radiation Therapy in Endometrial Carcinoma.
C L Creutzberg, W L van Putten, P C Koper...
https://pubmed.ncbi.nlm.nih.gov/10791524A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study.
Henry M Keys, James A Roberts, Virginia L Brunetto...
https://pubmed.ncbi.nlm.nih.gov/14984936