The purpose of this study is to compare the anti-emetic effect of ramosetron plus aprepitant and dexamethasone with palonosetron plus aprepitant and dexamethasone in patients receiving highly emetogenic chemotherapy.
Currently, palonosetron is the clinically preferred antiemetic for Chemotherapy-induced nausea and vomiting (CINV).However the best 5-hydroxytryptamine 3 receptor (5-HT3R) antagonists for use in a triple drug combination for high emetogenic chemotherapy(HEC) has not yet been determined in randomized trials. Previous anti-emetic guidelines stated that the anti-emetic activities of 5-HT3R antagonists were similar at equivalent doses. Based on the meta-analysis of various 5-HT3R antagonists in double regimens, the NCCN guideline has suggested palonosetron as a preferred 5-HT3R antagonist in the triple antiemetic drug combination. But in Asia, RAD is one of the most popular treatments for HEC-treated cancer patients. However, the lack of clinical studies has precluded the recommendation of RAD as a standard regimen for HEC-induced CINV. In two previous studies conducted in Korea, RAD regimen showed significant efficacy for prevention of CINV which is comparable to the efficacy reported from the studies evaluating with PAD regimen. If the efficacy of RAD regimen is evidently proven by this kind of randomized multicenter-trial, RAD regimen can be more recommended as a standard regimen for HEC-induced CINV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
292
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
palonosetron 0.25 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
St. Vincent'S Hospital
Suwon, Gyeonggi-do, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chungnam National University Hospita
Daejeon, South Korea
Pusan National University Hospital
Pusan, South Korea
To compare the overall complete response (CR) of RAD to PAD (Overall CR defined as no emesis, no rescue medication, at cycle 1
Time frame: 0-120 hours
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Kangbuk Samsung Hospital
Seoul, South Korea
Kangdong Sacred Heart Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea