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| Name | Class |
|---|---|
| The Catholic University of Korea | OTHER |
| Astellas Pharma Korea, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ramosetron, aprepitant, dexamethasone | Experimental |
|
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| palonosetron, aprepitant, dexamethasone | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ramosetron, aprepitant, dexamethasone | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the overall complete response (CR) of RAD to PAD (Overall CR defined as no emesis, no rescue medication, at cycle 1 | 0-120 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Hyoung Kang, Ph.D | The Catholic University of Korea | Principal Investigator |
| Jung Hye Kwon, PhD | Kangdong Sacred Heart Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent'S Hospital | Suwon | Gyeonggi-do | 16247 | South Korea | ||
| Keimyung University Dongsan Medical Center |
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| palonosetron, aprepitant, dexamethasone | Drug | 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 |
|
|
| Daegu |
| South Korea |
| Chungnam National University Hospita | Daejeon | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C071315 | ramosetron |
| D000077608 | Aprepitant |
| D003907 | Dexamethasone |
| D000077924 | Palonosetron |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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