Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin
Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group
study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist
(fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting)
control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer
diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy.
The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug
regimen (standard treatment) in preventing nausea and vomiting in patients receiving
radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of
patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and
it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase
the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.