The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study): Prospective multicenter, randomized, single blinded, phase III study.
To assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study):
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
338
ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
Hyo Jung Kim
Anyang-si, Gyeonggi-do, South Korea
RECRUITINGcomplete response (CR)
CR means no vomiting \& no rescue medication
Time frame: acute phase (within 24 hrs after onset of chemotherapy)
complete response
Delayed phase means 'from day 2 to day 5' after onset of chemotherapty whole study period means 'from day 1 to day 5' after onset of chemotherapty (acute phase + delayed phase).
Time frame: during delayed phase and whole study period
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