RecruitingPhase 3NCT03422198

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

Short Course Adjuvant Vaginal Cuff Brachytherapy (VCB) in Early Endometrial Cancer Compared to Standard of Care (SAVE)

Sponsor

University of Utah

Enrollment

188 participants

Start Date

Feb 2, 2018

Study Type

INTERVENTIONAL

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

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This trial is testing a shorter course of vaginal radiation therapy (brachytherapy) after surgery for early-stage uterine (endometrial) cancer, to see if fewer radiation treatments are just as effective with fewer side effects. **You may be eligible if...** - You have been diagnosed with early-stage uterine cancer (stage I or II) confirmed by tissue analysis - Your cancer type and grade meets specific criteria (various combinations including endometrioid, serous, clear cell, or carcinosarcoma) - You have had surgery to remove your uterus - Your doctor has recommended vaginal cuff brachytherapy (internal radiation) as part of your treatment **You may NOT be eligible if...** - Your cancer has spread significantly beyond the uterus (certain stage III/IV cases) - You have previously received pelvic radiation - You have serious other medical conditions that would make radiation unsafe - You are pregnant 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

RADIATIONVaginal Cuff Brachytherapy

Undergo standard of care vaginal cuff brachytherapy

RADIATIONShort course vaginal cuff brachytherapy

Undergo short course vaginal cuff brachytherapy

Locations(5)

Stanford Cancer Center

Palo Alto, California, United States

Loyola University Medical Center

Maywood, Illinois, United States

MD Anderson

Houston, Texas, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Intermountain Medical Center / LDS Hospital

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT03422198

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