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| Name | Class |
|---|---|
| Korean Cancer Study Group | OTHER |
| Astellas Pharma Korea, Inc. | INDUSTRY |
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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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ramosetron, aprepitant, dexamethasone | Experimental | 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, aprepitant, dexamethasone | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ramosetron | 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 |
|---|---|---|
| complete response (CR) | CR means no vomiting & no rescue medication | acute phase (within 24 hrs after onset of chemotherapy) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | during delayed phase and whole study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyo Jung Kim, M.D. Ph.D. | Contact | 82313803704 | hemonc@hallym.or.kr | |
| Jinjoo Hong, R.N. | Contact | 82232763517 | datacenter7@kcsg.org |
| Name | Affiliation | Role |
|---|---|---|
| Sangwon Shin, M.D. | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hyo Jung Kim | Recruiting | Anyang-si | Gyeonggi-do | 431070 | South Korea |
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| 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 |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| ondansetron | Drug | 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 |
|
|
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |