RecruitingPhase 3

Vaginal Cuff Brachytherapy Fractionation Study

United States258 participantsStarted 2019-01-17

Plain-language 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

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 agents administered more than 4 weeks prior to the on-study date * Subjects that require \> 14 weeks between surgery and initiation of radiation therapy on study unless the subject is receiving chemotherapy. Subjects receiving chemotherapy may have radiation therapy initiated within 6 months after surgery. \* Subjects who do not meet this criteria may still be eligible. The UVA Coordinating Center and Overall Study PI will review each case and inform the site of the approval decision. * Subjec…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Female Sexual Function Index (FSFI)

Timeframe: 1 year

Preference Option Randomized Design (PORD)

Timeframe: 1 year

Trial details

NCT IDNCT03785288

SponsorKara Romano, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-30

Contact for this trial

Song Wood

434-243-0008 UVARADONCClinicalTrials@uvahealth.org

View on ClinicalTrials.gov More Endometrial Cancer trials