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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-24

Study Completion Date

2022-11-04

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).

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Weekly Arm

fosaprepitant 150mg/m2 weekly in concurrent with radiotherapy during concurrent chemoradiotherapy

Group Type EXPERIMENTAL

fosaprepitant

Intervention Type DRUG

fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy

Triweekly Arm

fosaprepitant 150mg/m2 triweekly in concurrent with chemotherapy during concurrent chemoradiotherapy

Group Type ACTIVE_COMPARATOR

fosaprepitant

Intervention Type DRUG

fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy

Interventions

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fosaprepitant

fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No