Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Weekly Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma: a Prospective Pilot Study

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: fosaprepitant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weekly Arm<br>fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy | Drug: fosaprepitant<br>* fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy<br>|
| Active Comparator: Triweekly Arm<br>fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy | Drug: fosaprepitant<br>* fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of subjects with complete response (CR) overall | defined as no emesis and no use of rescue therapy | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of subjects with complete control (CC) overall | defined as no emesis and no use of rescue therapy and no significant nausea | 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 | defined as no or mild nausea | 7 weeks | 
| the proportion of subjects with CR in the 24 hours following initiation of radiotherapy and concomitant cisplatin | defined as no emesis and no use of rescue therapy | 24 hours | 
| the proportion of subjects with CR in the 120 hours following initiation of radiotherapy and concomitant cisplatin | defined as no emesis and no use of rescue therapy | 120 hours | 
| the mean time to first emetic episode |  | 7 weeks | 
| Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall |  | 7 weeks | 
| Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) overall |  | 7 weeks |