Spots Global Cancer Trial Database for Ramosetron, Aprepitant, and Dexamethasone Versus Palonosetron, Aprepitant, and Dexamethasone
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Trial Identification
Brief Title: Ramosetron, Aprepitant, and Dexamethasone Versus Palonosetron, Aprepitant, and Dexamethasone
Official Title: Comparison of Ramosetron, Aprepitant, and Dexamethasone (RAD) With Palonosetron, Aprepitant, and Dexamethasone (PAD) for Prevention of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
Study ID: NCT02532634
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Vincent'S Hospital, Suwon, Gyeonggi, Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Chungnam National University Hospita, Daejeon, , Korea, Republic of
Pusan National University Hospital, Pusan, , Korea, Republic of
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Kangdong Sacred Heart Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon, , Korea, Republic of
Contact Details
Name: Jin-Hyoung Kang, Ph.D
Affiliation: The Catholic University of Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Jung Hye Kwon, PhD
Affiliation: Kangdong Sacred Heart Hospital
Role: STUDY_DIRECTOR
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