Nausea, Vomiting, Genital Neoplasms, Female
Conditions
Keywords
Randomized Controlled Trial, Serotonin Agonists, Dexamethasone, Receptors, Neurokinin-1, Radiotherapy, Cisplatin, Prevention & control
Brief 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.
Interventions
Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.
DRUGPlacebo
Saline water
Sponsors
Helsinn Healthcare SA
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(abbreviated) 1. The patient has a diagnosis cervical cancer. 2. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent. 3. The patient is aged \> 18 years. 4. The patient must be both chemo- and radiotherapy (RT) naïve. NB: previously low voltage RT or electron RT for non-melanoma skin cancers is allowed. 5. The patient is scheduled to receive fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2 for at least five weeks. 6. Brachy therapy is scheduled to be initiated after the third cycle of weekly cisplatin, and preferentially after the fifth week of treatment. 7. Chemotherapy with an emetic risk potential of minimal or mild (up to 30%) is allowed on days 1-4 (see ref. 14). 8. The patient has a WHO Performance Status of ≤ 2.
Exclusion criteria
(abbreviated) 1. The patient has a current malignant diagnosis other than cervical cancer, with exception of non-melanoma skin cancers. 2. The patient is aged \< 18 years. 3. The patient is scheduled to receive less than five weeks of fractionated radiotherapy and concomitant weekly cisplatin. 4. Brachy therapy is planned to be initiated before the third cycle of weekly cisplatin. 5. The patient has been previously treated with radiotherapy, and/or chemotherapy, with exception of treatment with low voltage RT or electron RT for non-melanoma skin cancers . 6. The patient has a WHO Performance Status of \> 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 35 days |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 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. | 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. | 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. | 7 days |
| To compare quality of life using the FLIE questionnaire. | 0-35 days |
| To compare tolerability of both regimens. | 0-35 days |
| To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the number of days to first emetic episode. | 0-35 days |
Countries
Australia, Denmark, Germany, Norway
Outcome results
None listed