NCT04636632已完成1 期
Weekly Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma: a Prospective Pilot Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the proportion of subjects with complete response (CR) overall
研究概览
简要总结
This is an opene-label, single center, randomized prospective pilot study to compare the efficacy of weekly versus triweekly fosaprepitant regimens for the prevention of nausea and emesis during concurrent chemoradiotherapy for nasopharyngeal carcinoma (NPC).
详细描述
Scheme:
Eligible fosaprepitant sensitive (complete response [defined as no emesis and no use of rescue antiemetics] during the overall phase [0 to 120 hours] of all cycles of cisplatin-based induction chemotherapy) NPC patients will be randomized to 2 arms at 1:1 ratio.
- Weekly Arm: fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy.
- Triweekly Arm: fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- •Stage II - IVa NPC patients (according to the 8th AJCC edition)
- •Male and no pregnant female
- •Scheduled for cisplatin-based induction chemotherapy (cisplatin≥ 70 mg/m2)and concomitant triweekly cisplatin
- •Fosaprepitant sensitive (complete response [defined as no emesis and no use of rescue antiemetics] during the overall phase [0 to 120 hours] of all cycles of cisplatin-based induction chemotherapy)
- •Age between 18-70
- •Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
- •Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <2.0×upper limit of normal (ULN)
- •Adequate renal function: creatinine clearance ≥60 ml/min
- •Satisfactory performance status: Karnofsky scale (KPS) ≥ 70
- •Without radiotherapy or chemotherapy
- •Patients must give signed informed consent
排除标准
- •Evidence of relapse or distant metastasis
- •Pregnancy or lactation
- •History of prior malignancy or previous treatment for NPC
- •Had other current malignant diagnoses apart from non-melanoma skin cancers
- •Emesis or clinically significant nausea (moderate or severe) in the 24 h before the first dose of study medication
- •Drugs with antiemetic activity were not allowed for the 24 h before receiving the first dose of study medication
- •Known history of central nervous system disease (e.g., a seizure disorder or brain metastases )
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
研究组 & 干预措施
Weekly Arm
Experimental
fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy
干预措施: fosaprepitant (Drug)
Triweekly Arm
Active Comparator
fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy
干预措施: fosaprepitant (Drug)
结局指标
主要结局
the proportion of subjects with complete response (CR) overall
时间窗: 7 weeks
defined as no emesis and no use of rescue therapy
次要结局
- the proportion of subjects with complete control (CC) overall(7 weeks)
- the proportion of subjects with sustained no emesis overall(7 weeks)
- the proportion of subjects with no nausea overall(7 weeks)
- the proportion of subjects with no significant nausea overall(7 weeks)
- the proportion of subjects with CR in the 24 hours following initiation of radiotherapy and concomitant cisplatin(24 hours)
- the proportion of subjects with CR in the 120 hours following initiation of radiotherapy and concomitant cisplatin(120 hours)
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall(7 weeks)
- the mean time to first emetic episode(7 weeks)
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) overall(7 weeks)
研究者
Ming-Yuan Chen
Professor
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
终止
不适用
A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical ProphylaxisDeep Vein ThrombosisCoronary Artery Bypass SurgeryVenous ThromboembolismNCT00789399Prairie Education and Research Cooperative78
已完成
不适用
A Pilot Study Exploring the Efficacy and Safety of Topical Oxybutynin 3% Gel for Primary Focal Hyperhidrosis in Adolescents and Young AdultsHyperhidrosisNCT02633371University of Colorado, Denver10
已完成
2 期
A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)Hepatitis D, ChronicNCT02731131Hoffmann-La Roche12
已完成
1 期
Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin DeficiencyAlpha1-Antitrypsin DeficiencyNCT02870309Grifols Therapeutics LLC4
已完成
1 期
A Phase I Study to Determine the Effect of Food on the Pharmacokinetic Profile of BPI-7711NSCLCNCT04135820Beta Pharma, Inc.16