Vaginal Cuff Brachytherapy Fractionation Study

A Randomized Phase III Trial of Two Standard Dose Fractionation Regimes for Adjuvant Vaginal Brachytherapy in Early Stage Endometrial Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Radiation: HDR vaginal brachytherapy

Detailed Description

Patients are randomized to HDR vaginal brachytherapy 7 Gy in 3 fractions prescribed at 5mm. Radiation delivered 4-12 weeks after surgery OR HDR vaginal brachytherapy 4Gy in 6 fractions prescribed at the cylinder surface. Patients have the option to request to decline their randomization and switch to the alternate treatment ARM if they prefer.

Radiation delivered 4-12 weeks after surgery. Participants in all Arms will receive standard vaginal dilator for use after treatment (to promote healing). 3 month, 1 year and 2 year follow up assessments are performed.

• Study Type: Interventional
• Enrollment (Anticipated): 258
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Songserea Wood, BS; Phone Number: 434-243-0008; Email: stw2g@hscmail.mcc.virginia.edu
• Study Contact Backup: Name: Dena Synder; Email: DS6HE@hscmail.mcc.virginia.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Medical Center (UMMC)
      • Sub-Investigator: Sally Cheston, MD
      • Principal Investigator: Sarah McAvoy, MD
      • Sub-Investigator: Elizabeth Nichols, MD
      • Sub-Investigator: Jack J Hong, MD, FACRO
  • New York
    • Syracuse, New York, United States, 13210
      • Recruiting
      • SUNY Upstate Medical University
      • Contact: Erin Bingham; Phone Number: 315-464-3603; Email: BinghamE@upstate.edu
      • Contact: Lindsay Noah-Vermillion; Email: noahverl@upstate.edu
      • Principal Investigator: Brittany Simone, DO
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
      • Contact: Kara Romano, MD; Email: KED7C@uvahealth.org
      • Contact: Song Wood; Email: STW2G@uvahealth.org
      • Principal Investigator: Kara Romano, MD
      • Sub-Investigator: Timothy Showalter, MD
      • Sub-Investigator: Leigh Cantrell, MD, MSPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM A: 3 treatments of 7Gy; Arm A: accepted randomization to HDR vaginal brachytherapy in 3 treatments (fractions) of 7Gy for a total dose of 21gy	Radiation: HDR vaginal brachytherapy; HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
Active Comparator: ARM B: 6 treatment of 4Gy; Arm B: accepted randomization to HDR vaginal brachytherapy 6 treatments (fractions) of 4Gy for a total does of 24gy	Radiation: HDR vaginal brachytherapy; HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
Active Comparator: ARM AB: 6 treatment of 4Gy; 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; HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions
Active Comparator: ARM BA: 3 treatments of 7Gy; 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; HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Length Measurement	Using vaginal dilator compare patient vaginal measurement 1 year after completion of treatment	1 year
Vaginal Length Measurement	Using vaginal dilator compare patient vaginal measurement 2 years after completion of treatment	2 years

Collaborators and Investigators

• Sponsor: Kara Romano, MD
• Investigators: Principal Investigator: Kara Romano, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: 20163 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No