Vaginal Cuff Brachytherapy Fractionation Study
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
| Condition(s) | Endometrial Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 o |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Kara Romano, MD |
| Locations | Baltimore, Maryland, United States; Syracuse, New York, United States; Charlottesville, Virginia, United States |
| Start date | 2019-01-17 |
| NCT ID | NCT03785288 |
| Official listing | https://clinicaltrials.gov/study/NCT03785288 |