Vaginal Cuff Brachytherapy Fractionation Study

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Kara Romano, MD
Study ID
NCT03785288
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HDR vaginal brachytherapy — RADIATION
    HDR vaginal brachytherapy 7 Gy in 3 fractions or HDR vaginal brachytherapy 4 Gy in 6 fractions

Study Details

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.

Key Dates

Start date
Jan 17, 2019
Status verified
Apr 2026
Primary completion
Jan 30, 2027
Completion
Jan 30, 2028

Study Design

Enrollment
258 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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
  • 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
  • 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

Primary Outcome Measure

Female Sexual Function Index (FSFI) [ Time Frame: 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Maryland Medical Center (UMMC)BaltimoreMaryland21201
Caitlin Eggleston
[email protected]
410-328-7586
Sarah McAvoy, MD (PRINCIPAL_INVESTIGATOR)
Elizabeth Nichols, MD (SUB_INVESTIGATOR)
Jack J Hong, MD, FACRO (SUB_INVESTIGATOR)
Sally Cheston, MD (SUB_INVESTIGATOR)
SUNY Upstate Medical UniversitySyracuseNew York13210
Erin Bingham
[email protected]
315-464-3603
Lindsay Noah-Vermillion
[email protected]
Brittany Simone, DO (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Kara Romano, MD
[email protected]
Song Wood
[email protected]
Kara Romano, MD (PRINCIPAL_INVESTIGATOR)
Timothy Showalter, MD (SUB_INVESTIGATOR)
Leigh Cantrell, MD, MSPH (SUB_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Maryland Medical Center (UMMC)· Baltimore, MDSUNY Upstate Medical University· Syracuse, NYUniversity of Virginia· Charlottesville, VA

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