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.
Protocol Amendment History
1 amendment
This ClinicalTrials.gov record has been amended once since 2023-11-01.
Status change: Not Yet Recruiting → Recruiting2024-09-23