Vaginal Cuff Brachytherapy Fractionation Study

NCT03785288 | Recruiting Phase 3 DMC

• 1 other identifier: 21063
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 3

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

• Female Sexual Function Index (FSFI)

  Using the FSFI, compare patient reported sexual dysfunction at 1 year after completion of treatment

  1 year

• Preference Option Randomized Design (PORD)

  Assessing the comparative effectiveness of receiving HDR vaginal brachytherapy on Arm B or Arm A for early stage endometrial cancer.

  1 year

Secondary Outcomes (2)

• Vaginal Length Measurement

  1 year

• Vaginal Length Measurement

  2 years

Study Arms (4)

ARM A: 3 treatments of 7Gy

ACTIVE COMPARATOR

Arm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy

Radiation: HDR vaginal brachytherapy

ARM B: 6 treatment of 4Gy

ACTIVE COMPARATOR

Arm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy

Radiation: HDR vaginal brachytherapy

ARM AB: 6 treatment of 4Gy

ACTIVE COMPARATOR

Arm AB: initially randomized to ARM A but wanted to switch to ARM B treatment of HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy

Radiation: HDR vaginal brachytherapy

ARM BA: 3 treatments of 7Gy

ACTIVE COMPARATOR

initially randomized to ARM B but wanted to switch to ARM A of HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy

Radiation: HDR vaginal brachytherapy

Interventions

HDR vaginal brachytherapy RADIATION

HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions

ARM A: 3 treatments of 7Gy; ARM AB: 6 treatment of 4Gy; ARM B: 6 treatment of 4Gy; ARM BA: 3 treatments of 7Gy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Subjects who are receiving any investigational agents or have had any investigational agent within the 30 days prior to the 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 a 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

Sponsors & Collaborators

• Kara Romano, MD: lead

Study Sites (3)

University of Maryland Medical Center (UMMC)

Baltimore, Maryland, 21201, United States

RECRUITING

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Kara Romano, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Song Wood

CONTACT

434-243-0008; UVARADONCClinicalTrials@uvahealth.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator-MD Radiation Oncology

Model Details: This study will compare two standard of care treatments: HDR vaginal brachytherapy 3 fractions of 7Gy to HDR vaginal brachytherapy 6 fractions of 4Gy for early stage endometrial cancer.

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: December 24, 2018
• Study Start: January 17, 2019
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (3)