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NCT03422198 · ClinicalTrials.gov registry record · Phase 3
Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer
A Phase 3 study of Endometrial Serous Adenocarcinoma and Endometrial Clear Cell Adenocarcinoma, sponsored by University of Utah.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
- 5
- Study locations
NCT03422198: Recruiting Phase 3 study of Endometrial Serous Adenocarcinoma and Endometrial Clear Cell Adenocarcinoma, sponsored by University of Utah.
NCT03422198 is a Phase 3 study of Endometrial Serous Adenocarcinoma and Endometrial Clear Cell Adenocarcinoma that is actively recruiting participants, run by University of Utah. The registered enrollment target is 188 participants, below the 286-participant average among 12 other Endometrial Serous Adenocarcinoma trials with a reported enrollment target (34% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03422198, a Phase 3 study of Endometrial Serous Adenocarcinoma and Endometrial Clear Cell Adenocarcinoma, is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- RADIATION Vaginal Cuff Brachytherapy
- RADIATION Short course vaginal cuff brachytherapy
Study Locations (5)
Utah
- Huntsman Cancer Institute/University of Utah - Salt Lake City
- Intermountain Medical Center / LDS Hospital - Salt Lake City
California
- Stanford Cancer Center - Palo Alto
Illinois
- Loyola University Medical Center - Maywood
Texas
- MD Anderson - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2018-02-02 |
| Est. Completion | 2029-10-31 |
| Phase | Phase 3 |
What NCT03422198 shows while recruiting
NCT03422198 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 286-participant average among 12 other Endometrial Serous Adenocarcinoma trials with a reported enrollment target (34% lower).
The record links to 9 conditions, with Endometrial Serous Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Vaginal Cuff Brachytherapy is the first listed.
NCT03422198 lists 5 locations in 4 states (Utah, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT03422198 about?
NCT03422198 is a clinical study titled "Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer". 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 th...
What is the current status of trial NCT03422198?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2018-02-02. Estimated completion is 2029-10-31.
What conditions does trial NCT03422198 study?
This clinical trial studies the following conditions: Endometrial Serous Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Stage I Uterine Corpus Cancer, Stage II Uterine Corpus Cancer.
What interventions are being tested in trial NCT03422198?
The interventions under investigation include: Vaginal Cuff Brachytherapy (RADIATION), Short course vaginal cuff brachytherapy (RADIATION).
Who is sponsoring clinical trial NCT03422198?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03422198 being conducted?
This trial has 5 study locations across California, Illinois, Texas, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03422198's enrollment target sits among peer trials
188 7th of 12 higher than 6 of 12 other Endometrial Serous Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Serous Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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