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

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.

Timeline

Start

2024-06-25

Primary completion

2027-06-01

Completion

2027-08-01

Publications

• Zietse M, Aalders LC, Spierings LEAMM, De Rouw N, Dercksen W, Dalm VASH, Oomen-de Hoop E, Thielen FW, Koch BCP, Mathijssen RHJ, van Doorn L, Leeuwen RWFV. Omission of dexamethasone in paclitaxel premedication regimens: protocol of the multicentre, randomised, non-inferiority DEXASTOP trial. BMJ Open. 2025 Apr 25;15(4):e102770. doi: 10.1136/bmjopen-2025-102770.

Drugs

Indications