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PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer

Study acronym: PORTEC-4a
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 11, 2023 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Dec 2025 to Dec 31, 2024 · Completion date: Dec 2028 to Dec 31, 2028 · Site details revised at 31 of 31 sitesv5 Show 3 more changesShow less
    • Primary completion date: Dec 2025 to Dec 31, 2024
    • Completion date: Dec 2028 to Dec 31, 2028
    • Site details revised at 31 of 31 sites
  2. Enrollment target: 500 to 550 Study sites: 23 to 31 · Primary completion date: Dec 2026 to Dec 2025 · Eligibility criteria expanded, about 1 wordv4 Show 3 more changesShow less
    • Study sites: 23 to 31
    • Primary completion date: Dec 2026 to Dec 2025
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Phase: Not applicable to Phase 3 Site details revised at 2 of 23 sitesv3 Show 1 more changeShow less
    • Site details revised at 2 of 23 sites
  4. Primary completion date: Dec 2021 to Dec 2026 Study sites: 18 to 23 · Completion date: Dec 2023 to Dec 2028 · Collaborators expanded, about 8 wordsv2 Show 3 more changesShow less
    • Study sites: 18 to 23
    • Completion date: Dec 2023 to Dec 2028
    • Collaborators expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is prospective, multicenter, randomised phase III trial among women with endometrial cancer with high-intermediate risk features to investigate the role of an integrated clinicopathological and molecular risk profile to determine if participants should receive no adjuvant therapy, vaginal brachytherapy or external beam radiotherapy based on a favourable, intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.
Trial Details
NCT Number NCT03469674
Lead Sponsor Leiden University Medical Center
Collaborators: Dutch Cancer Society, Comprehensive Cancer Centre The Netherlands
Conditions Endometrial Cancer Stage I, Endometrial Cancer Stage II
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov