RecruitingPhase 3NCT03785288

Vaginal Cuff Brachytherapy Fractionation Study

A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer


Sponsor

Kara Romano, MD

Enrollment

258 participants

Start Date

Jan 17, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to see the effects of two different standard of care treatments of endometrial cancer on sexual dysfunction. This study will compare two standard of care treatments: HDR (high dose radiation) vaginal brachytherapy 3 fractions of 7 Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different dosing schedules of vaginal cuff brachytherapy — a type of internal radiation therapy delivered directly to the vaginal area after a hysterectomy (surgery to remove the uterus) for endometrial (uterine) cancer. The goal is to find which schedule is most effective with the fewest side effects. **You may be eligible if...** - You have had a total hysterectomy (removal of the uterus and ovaries) for endometrial cancer - Your cancer is a specific low-to-intermediate risk type based on pathology - You are willing and able to follow the study procedures and provide consent **You may NOT be eligible if...** - Your cancer has spread beyond the uterus at the time of surgery - You have already received external pelvic radiation therapy - You have a different cancer type not covered by the study criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHDR vaginal brachytherapy

HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions


Locations(3)

University of Maryland Medical Center (UMMC)

Baltimore, Maryland, United States

SUNY Upstate Medical University

Syracuse, New York, United States

University of Virginia

Charlottesville, Virginia, United States

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NCT03785288


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