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

Sun Yat-sen University

Status and phase

Completed

Phase 1

Conditions

Nasopharyngeal Carcinoma

Treatments

Drug: fosaprepitant

Study type

Interventional

Funder types

Other

Identifiers

NCT04636632

SYSUCC-MYC-2020-1104

Details and patient eligibility

About

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).

Full description

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.

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.