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

NCT03422198 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-12-12

Study results available
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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
  • Stage IB Uterine Corpus Cancer
  • Stage II Uterine Corpus Cancer
  • Uterine Corpus Carcinosarcoma
  • Uterine Corpus Sarcoma

Interventions

RADIATION

Vaginal Cuff Brachytherapy

Undergo standard of care vaginal cuff brachytherapy

RADIATION

Short course vaginal cuff brachytherapy

Undergo short course vaginal cuff brachytherapy

Sponsors & Collaborators

Principal Investigators

  • Cristina DeCesaris, MD · Huntsman Cancer Institute/ University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-02
Primary Completion
2026-11-30
Completion
2029-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03422198 on ClinicalTrials.gov