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

• Status: Recruiting
• Trial end date: 2021-04-11
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Aprepitant; Fosaprepitant

Criteria

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 and concomitant triweekly cisplatin (≥ 70 mg/m2)

• 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.