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Recruiting Phase 3 NCT03785288

Vaginal Cuff Brachytherapy Fractionation Study

Trial Parameters

Condition Endometrial Cancer
Sponsor Kara Romano, MD
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 258
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2019-01-17
Completion 2025-01-01
Interventions
HDR vaginal brachytherapy

Brief 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 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 dissection. * Subject must have FIGO Stage I-II (grade 1-3) pathologically proven (histologic) endometrioid cancer, including all subtypes. Serous, clear cell, and carcinosarcoma histologic pathologies are allowed. * Subjects must have no measurable disease after surgery. * ECOG Performance Status of 0-2 * Age ≥ 18 years * Subject must have a life expectancy ≥ 12 months Exclusion Criteria: * Disease of more advanced stage (FIGO stage III-IV) or disease for which adjuvant external beam radiation therapy or chemotherapy is indicated * Patients with a history of prior pelvic radiation therapy or if additional pelvic radiation therapy is planned * Subjects who have not recovered from side effects of agen

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