Charlottesville, Virginia 22903


Purpose:

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 (Arm 1) to HDR vaginal brachytherapy 6 fractions of 4Gy (Arm 2) for early stage endometrial cancer.


Study summary:

Patients are randomized to Arm 1: HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at 5mm. Radiation delivered 4-12 weeks after surgery OR Arm 2: HDR vaginal brachytherapy 4Gy in 6 fractions prescribed at the cylinder surface. Radiation delivered 4-12 weeks after surgery. Participants in both arms will receive standard vaginal dilator for use after treatment (to promote healing). 1 and 2 year follow up assessments are performed.


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 history of prior pelvic radiation therapy or if additional pelvic radiation therapy is planned - Subjects who have not recovered from side effects of agents administered more than 4 weeks prior to on-study date - Subjects that require > 14 weeks between surgery and initiation of radiotherapy on study - Subjects who are receiving any investigational agents or have had any investigational agent within the 30 days prior to on-study date - Subject is unable or unwilling to participate in a study related procedure - Pregnant and breastfeeding women are excluded from this study - Subject is a prisoner - A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy.-Subjects with history of evidence upon physical examination of central nervous system disease including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (stroke), transient ischemic attack, or subarachnoid hemorrhage within six months of study entry


NCT ID:

NCT03785288


Primary Contact:

Principal Investigator
Timothy Showalter, MD
University of Virginia

Amy Smith, BS
Phone: 434-243-7231 ext. 3-7231
Email: ajb6bb@hscmail.mcc.virginia.edu


Backup Contact:

Email: TNS3B@hscmail.mcc.virginia.edu
Timothy Showalter, MD
Phone: (434) 924-9412 ext. 4-9412


Location Contact:

Charlottesville, Virginia 22903
United States

Timothy Showalter, MD
Email: TNS3B@hscmail.mcc.virginia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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