Clinical trial NCT01536691: Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer
Malignancy
Keywords: ramosetron
ondansetron
aprepitant
chemotherapy induced nausea & vomiting
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
Collaborators: name: Korean Cancer Study Group
name: Astellas Pharma Korea, Inc.
First posted: 2012-02-22
Enrollment: 338
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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):

Eligibility criteria: 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

Primary outcomes:
measure: complete response (CR)
timeFrame: acute phase (within 24 hrs after onset of chemotherapy)
Secondary outcomes:
measure: complete response
timeFrame: during delayed phase and whole study period
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hyo Jung Kim
state: Gyeonggi-do
Study officials:
affiliation: Korea University Anam Hospital
name: Sangwon Shin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: