Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone

Study Overview
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Brief Summary
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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.

Detailed Description
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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):

Official Title
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To Assess the Efficacy and Safety of Ramosetron, Aprepitant and Dexamethasone Therapy vs Ondansetron, Aprepitant and Dexamethasone Therapy for Preventing of Nausea and Vomiting in Highly Emetogenic Chemotherapy (ROAD Study)

Conditions
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Cancer, Malignancy

Intervention / Treatment
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* Drug: ramosetron
* Drug: ondansetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as malignancy who will be treated with highly emetogenic chemotherapeutic agents (NCCN guideline v1.0 2011 anti-emesis), over 20 years and both sex ECOG performance status 0-2 Available oral administration of study drugs Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital Exclusion Criteria: Severe Hypertension, severe Heart disease, kidney disease (serum creatinine > 3 mg/dl), liver disease (AST, ALT > 3 times of upper normal range, ALP > 2 times of upper normal range) Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting Patients who have nausea and vomiting within 1 week before chemotherapy Patients who should take steroid, antiemetics, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir for the treatment of other diseases Patients with brain tumor, brain metastasis or seizure Patients receiving chemotherapy within 12 months before enrollment Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy Patients who have known allergy or severe side effect on study drugs Pregnant or lactating women, or women who wish to become pregnant Others whom the investigator judges inappropriate as subjects for this study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ramosetron, aprepitant, dexamethasone<br>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 | Drug: ramosetron<br>* 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<br>* Other names: Emend - aprepitant;|
| Active Comparator: ondansetron, aprepitant, dexamethasone<br>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 | Drug: ondansetron<br>* 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<br>* Other names: Emend - aprepitant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response (CR) | CR means no vomiting & no rescue medication | acute phase (within 24 hrs after onset of chemotherapy) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ramosetron, ondansetron, aprepitant, chemotherapy induced nausea & vomiting