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Evaluation of the Omission of Dexamethasone in Premedication Regimens During Paclitaxel Treatment

Study acronym: DEXASTOP
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 1, 2024 to Jun 25, 2024 · Primary completion date: Jan 1, 2027 to Jun 1, 2027 · Site details revisedv2 Show 3 more changesShow less
    • Start date changed from estimate of Jan 1, 2024 to Jun 25, 2024
    • Primary completion date: Jan 1, 2027 to Jun 1, 2027
    • Site details revised
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 prospective multicenter randomized non-inferiority trial aims to assess whether omitting dexamethasone from the premedication regimen during paclitaxel-based chemotherapy is non-inferior to the standard of care regimen that includes dexamethasone, based on the incidence of clinically relevant hypersensitivity reactions (HSRs) of grade ≥3 as per CTCAE v5.0. With a study population of 500 adult patients with solid tumors, the trial will also investigate secondary endpoints including the severity and incidence of HSRs of any grade, the number of paclitaxel administrations until the first HSR, the impact on patients' quality of life, adverse events related to dexamethasone, and the cost-effectiveness of the two premedication regimens from healthcare and societal perspectives.
Trial Details
NCT Number NCT06118710
Lead Sponsor Erasmus Medical Center
Conditions Cancer
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov