Steroid-free Regimen With Aprepitant in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer Receiving FOLFOX Chemotherapy: a Randomized Phase 3 Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Complete response
研究概览
简要总结
Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of colorectal cancer
- •No prior chemotherapy and scheduled to receive FOLFOX chemotherapy (oxaliplatin,leucovorin and 5-fluorouracil)
- •Age ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
- •Laboratory index: Hemoglobin ≥ 90 g/L (No blood transfusion within 14 days), Absolute Neutrophil Count ≥ 1.5×10^9/L, Platelet Count ≥ 75×10^9/L, Serum Bilirubin ≤ 1.5×ULN, ALT and AST ≤ 3.0×ULN (without liver metastases), ALT and AST ≤ 5.0×ULN (with liver metastases), Serum Creatinine ≤ 1×ULN, Endogenous Creatinine Clearance>60ml/min
- •Be able to read, understand and complete the questionnaire and diary
- •Be able to understand the study procedures and sign informed consent.
排除标准
- •Treatment with any other study medicine within 4 weeks before enrollment.
- •Nausea or vomiting ≤ 24 hours prior to registration
- •Ongoing emesis due to obstruction of digestive tract
- •Concurrent use of olanzapine, phenothiazine or amifostine
- •Female with pregnancy or lactation
- •Severe cognitive compromise
- •Known history of CNS disease (e.g. brain metastases, seizure disorder)
- •Concurrent abdominal radiotherapy
- •Chronic alcoholism
- •Known hypersensitivity to aprepitant, tropisetron, or dexamethasone.
- •Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months.
- •History of uncontrolled diabetes mellitus
- •Serious or uncontroled infection
- •Known active HIV, viral hepatitis or tuberculosis infections
研究组 & 干预措施
Aprepitant arm
Aprepitant + Tropisetron
干预措施: Aprepitant+Tropisetron (Drug)
Control arm
Dexamethasone+ Tropisetron
干预措施: Dexamethasone+Tropisetron (Drug)
结局指标
主要结局
Complete response
时间窗: Day 1 to Day 5 after chemotherapy
No emetic episodes and no use of rescue medication
次要结局
- Nausea score(Day 1 to Day 5 after chemotherapy)
- Frequency of rescue medication(Day 1 to Day 5 after chemotherapy)
- Time to First Vomiting Episode or Use of Rescue Medication(Day 1 to Day 5 after chemotherapy)
- Complete response in the acute phase (0-24 hours)(0 to 24 hours after chemotherapy)
- Complete response in the delay phase (25 hours-120 hours)(Day 2 to Day 5 (25 hours-120 hours) after chemotherapy)
研究者
Yanhong Deng
Associate professor
Sun Yat-sen University