Clinical trial NCT04636632: Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma
Official title: Weekly Fosaprepitant for the Prevention of Nausea and Emesis During Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility 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 (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.

Primary outcomes:
measure: the proportion of subjects with complete response (CR) overall
timeFrame: 7 weeks
Secondary outcomes:
measure: the proportion of subjects with complete control (CC) overall
timeFrame: 7 weeks
measure: the proportion of subjects with sustained no emesis overall
timeFrame: 7 weeks
measure: the proportion of subjects with no nausea overall
timeFrame: 7 weeks
measure: the proportion of subjects with no significant nausea overall
timeFrame: 7 weeks
measure: the proportion of subjects with CR in the 24 hours following initiation of radiotherapy and concomitant cisplatin
timeFrame: 24 hours
measure: the proportion of subjects with CR in the 120 hours following initiation of radiotherapy and concomitant cisplatin
timeFrame: 120 hours
measure: the mean time to first emetic episode
timeFrame: 7 weeks
measure: Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall
timeFrame: 7 weeks
measure: Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) overall
timeFrame: 7 weeks
Other outcomes:
measure: Progress-free survival (PFS)
timeFrame: 1 year
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming-Yuan Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: