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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636632
• Other study ID #: SYSUCC-MYC-2020-1104
• Status: Completed
• Phase: Phase 1
• Start date: November 24, 2020
• Est. completion date: November 4, 2022

Study information

• Verified date: November 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• fosaprepitant
fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progress-free survival (PFS)		1 year
Primary	the proportion of subjects with complete response (CR) overall	defined as no emesis and no use of rescue therapy	7 weeks
Secondary	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
Secondary	the proportion of subjects with sustained no emesis overall		7 weeks
Secondary	the proportion of subjects with no nausea overall		7 weeks
Secondary	the proportion of subjects with no significant nausea overall	defined as no or mild nausea	7 weeks
Secondary	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
Secondary	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
Secondary	the mean time to first emetic episode		7 weeks
Secondary	Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) overall		7 weeks
Secondary	Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) overall		7 weeks