Evaluation of the Omission of Dexamethasone in Premedication Regimens During Paclitaxel Treatment
Status:
Not yet recruiting
Trial end date:
2027-08-01
Target enrollment:
Participant gender:
Summary
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.