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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
246
Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.
Saline water
RAH Cancer Centre, Royal Adelaide Hospital
Adelaide SA, Australia
Department of Oncology
Aarhus, Denmark
Rigshospitalet, Finsen Centret
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Department of Oncology, Odense University Hospital
Odense, Denmark
Vivantes Klinikum Neukolln
Berlin, Germany
Universitatsklinikum Schleswig Holstein
Kiel, Germany
The Norwegian Radium Hospital
Oslo, Norway
To compare fosaprepitant dimeglumine, palonosetron, and dexamethasone with palonosetron, dexamethasone, and placebo with respect to efficacy; the proportion of subjects with no vomiting during five weeks of radiotherapy and concomitant weekly cisplatin.
Time frame: 35 days
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with complete response in the 7 days following initiation of radiotherapy and concomitant weekly cisplatin.
Time frame: 7 days
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with no significant nausea during five weeks of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
Time frame: 35 days
To compare the fosaprepitant dimeglumine regimen and the control regimen with respect to complete response in the 35 days following initiation of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
Time frame: 35 days
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with no nausea during five weeks (35 days) of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
Time frame: 35 days
To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the number of days to first emetic episode.
Time frame: 0-35 days
To compare quality of life using the FLIE questionnaire.
Time frame: 0-35 days
To compare tolerability of both regimens.
Time frame: 0-35 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.