Vaginal Cuff Brachytherapy Fractionation Study

Recruiting Phase 3 Interventional Study
Endometrial Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
258 (estimated)
Sponsor
Kara Romano, MD · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator. * Surgery consisted of Total Abdominal or Laparoscopic Hysterectomy and Bilateral Salpingo Oophorectomy (TH-BSO) with or without lymph node dissecti…
Contacts

Song Wood

434-243-0008

UVARADONCClinicalTrials@uvahealth.org

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