Cancer, Malignancy
Conditions
Keywords
ramosetron, ondansetron, aprepitant, chemotherapy induced nausea & vomiting
Brief summary
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
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):
Interventions
DRUGramosetron
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
DRUGondansetron
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
Sponsors
Korean Cancer Study Group
Astellas Pharma Korea, Inc.
Hallym University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. ECOG performance status 0-2 3. Available oral administration of study drugs 4. 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
1. 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) 2. Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting 3. Patients who have nausea and vomiting within 1 week before chemotherapy 4. 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 5. Patients with brain tumor, brain metastasis or seizure 6. Patients receiving chemotherapy within 12 months before enrollment 7. Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy 8. Patients who have known allergy or severe side effect on study drugs 9. Pregnant or lactating women, or women who wish to become pregnant 10. Others whom the investigator judges inappropriate as subjects for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete response (CR) | acute phase (within 24 hrs after onset of chemotherapy) | CR means no vomiting & no rescue medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete response | during delayed phase and whole study period | 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). |
Countries
South Korea
Contacts
Primary ContactHyo Jung Kim, M.D. Ph.D.
Backup ContactJinjoo Hong, R.N.
Outcome results
None listed