Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer

Part of paid clinical trials in Palo Alto, California.

Sponsor
University of Utah
Study ID
NCT03422198
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Endometrioid Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Stage I Uterine Corpus Cancer
  • Stage IA Uterine Corpus Cancer
  • Stage IB Uterine Corpus Cancer
  • Stage II Uterine Corpus Cancer
  • Uterine Corpus Carcinosarcoma
  • Uterine Corpus Sarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vaginal Cuff Brachytherapy — RADIATION
    Undergo standard of care vaginal cuff brachytherapy
  • Short course vaginal cuff brachytherapy — RADIATION
    Undergo short course vaginal cuff brachytherapy

Study Details

This randomized phase III trial studies short course vaginal cuff brachytherapy to see how well it works compared with standard of care vaginal cuff brachytherapy in treating participants with stage I-II endometrial cancer. Short course vaginal cuff brachytherapy, also known as internal radiation therapy, uses (over a shorter period) radioactive material placed directly into or near a tumor in the upper portion of the vagina to kill tumor cells. After completion of cohort 1 (108 participants), the protocol was expended to add a second cohort of 80 additional participants, and re-opened study recruitment.

Key Dates

Start date
Feb 2, 2018
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
Oct 31, 2029

Study Design

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

Arms

  • Experimental: Short course vaginal cuff brachytherapy
    Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
  • Active Comparator: Vaginal cuff brachytherapy
    Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.

Primary Outcome Measure

Change in Quality of Life From Baseline to 1 Month [ Time Frame: At 1 month post treatment ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterPalo AltoCalifornia94304-
Loyola University Medical CenterMaywoodIllinois60153
Carly Quick, RN
[email protected]
708-327-3255
Lorena Leon
[email protected]
464-220-9395
William Small, MD (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
Mathew G Geena
[email protected]
713-792-4594
Anuja Jhingran, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112
Rachel Kingsford
[email protected]
801-585-0115
Cristina DeCesaris, MD (PRINCIPAL_INVESTIGATOR)
Intermountain Medical Center / LDS HospitalSalt Lake CityUtah84143-

Find similar trials in Palo Alto, CA

By research site
Stanford Cancer Center· Palo Alto, CALoyola University Medical Center· Maywood, ILMD Anderson· Houston, TXHuntsman Cancer Institute/University of Utah· Salt Lake City, UTIntermountain Medical Center / LDS Hospital· Salt Lake City, UT

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