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

Study acronym: SAVE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jan 30, 2018 to Feb 2, 2018 Study description shortened, about 55 words · Site details revised at 1 of 5 sites · Eligibility criteria expanded, about 2 words · 1 morev22 Show 4 more changesShow less
    • Study description shortened, about 55 words
    • Site details revised at 1 of 5 sites
    • Eligibility criteria expanded, about 2 words
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study description shortened, about 5 wordsv21 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv20
  4. Eligibility criteria expanded, about 12 words Study description shortened, about 2 wordsv19 Show 1 more changeShow less
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 1 of 5 sitesv18
Show 16 earlier versionsHide 16 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 108 to 188 · Primary completion date: Dec 2, 2021 to Nov 30, 2026 · Primary endpoints: 1 to 2 · 6 morev17 Show 9 more changesShow less
    • Enrollment target: 108 to 188
    • Primary completion date: Dec 2, 2021 to Nov 30, 2026
    • Primary endpoints: 1 to 2
    • Completion date: Sep 2024 to Oct 31, 2029
    • Eligibility criteria revised
    • Secondary endpoints: 2 to 5
    • Study description expanded, about 97 words
    • Site details revised at 5 of 5 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv16
  3. Secondary endpoints: details revised at 1 of 2 entriesv15
  4. Results first posted: Dec 23, 2022 Primary endpoint revised · Secondary endpoints revised (2)v14 Show 2 more changesShow less
    • Primary endpoint revised
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv13
  6. Study sites: 3 to 5v12
  7. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Jan 8, 2022 to Dec 2, 2021 · Completion date: Jan 8, 2022 to Sep 2024 · Start date: Jan 17, 2018 to Jan 30, 2018 · 1 morev11 Show 4 more changesShow less
    • Primary completion date changed from estimate of Jan 8, 2022 to Dec 2, 2021
    • Completion date: Jan 8, 2022 to Sep 2024
    • Start date: Jan 17, 2018 to Jan 30, 2018
    • Site details revised at 3 of 3 sites
  8. Study description expanded, about 36 wordsv10 See this version in full on ClinicalTrials.gov ↗
  9. Study description expanded, about 38 words Eligibility criteria shortened, about 5 wordsv9 Show 1 more changeShow less
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  10. Site contacts updated at 1 of 3 sitesv8
  11. 3 versions Re-verified since Oct 1, 2019, no change to tracked fieldsv5-v7
  12. Study sites: 2 to 3v4
  13. Study sites: 1 to 2 Eligibility criteria shortened, about 4 wordsv3 Show 1 more changeShow less
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  14. Eligibility criteria expanded, about 25 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03422198
Lead Sponsor University of Utah
Collaborators: Huntsman Cancer Institute
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 +1 more
Enrollment 188 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov