Recruiting
Phase 3

Vaginal Cuff Brachytherapy

Sponsor:

University of Utah

Code:

NCT03422198

Conditions

Endometrial Clear Cell Adenocarcinoma

Endometrial Endometrioid Adenocarcinoma

Endometrial Serous Adenocarcinoma

Stage I Uterine Corpus Cancer

Stage IA Uterine Corpus Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Vaginal Cuff Brachytherapy

Short course vaginal cuff brachytherapy

Study Details

Brief summary:

This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells.

After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.

Conditions

Endometrial Clear Cell Adenocarcinoma

Endometrial Endometrioid Adenocarcinoma

Endometrial Serous Adenocarcinoma

Stage I Uterine Corpus Cancer

Stage IA Uterine Corpus Cancer

Study ID

NCT03422198

Start date

Feb 2, 2018

Status verified date

Sep, 2025

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Short course vaginal cuff brachytherapy

Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.

active comparator: Vaginal cuff brachytherapy

Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.

Interventions

Vaginal Cuff Brachytherapy

Undergo standard of care vaginal cuff brachytherapy

Short course vaginal cuff brachytherapy

Undergo short course vaginal cuff brachytherapy

Primary outcome measure

  • Change in Quality of Life From Baseline to 1 Month [ Time Frame: At 1 month post treatment ]
  • Cohort 2: Participant-Reported Financial Toxicity [ Time Frame: One month after brachytherapy ]

Central Contacts and Locations

Central contacts

Rachel Kingsford

801-585-0115Rachel.Kingsford@hci.utah.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Carly Quick, RN

708-327-3255Carly.quick@luhs.org

Lorena Leon

464-220-9395lleon4@luc.edu

Principal Investigator:

William Small, MD

MD Anderson

Recruiting

Houston, Texas, United States, 77030

Contacts

Mathew G Geena

713-792-4594geenag@mdanderson.org

Principal Investigator:

Anuja Jhingran, MD

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Rachel Kingsford

801-585-0115rachel.kingsford@hci.utah.edu

Principal Investigator:

Cristina DeCesaris, MD

More Information

Sponsor

University of Utah

Last update posted

Dec 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-12-12.