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)
试验速览
- 阶段
- 3 期
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- complete response (CR)
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ramosetron, aprepitant, dexamethasone
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
干预措施: ramosetron (Drug)
ondansetron, aprepitant, dexamethasone
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
干预措施: ondansetron (Drug)
结局指标
主要结局
complete response (CR)
时间窗: acute phase (within 24 hrs after onset of chemotherapy)
CR means no vomiting \& no rescue medication
次要结局
- complete response(during delayed phase and whole study period)