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

NCT04636632 | Completed Phase 1 DMC

• 1 other identifier: SYSUCC-MYC-2020-1104
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• the proportion of subjects with complete response (CR) overall

  defined as no emesis and no use of rescue therapy

  7 weeks

Secondary Outcomes (9)

• the proportion of subjects with complete control (CC) overall

  7 weeks

• the proportion of subjects with sustained no emesis overall

  7 weeks

• the proportion of subjects with no nausea overall

  7 weeks

• the proportion of subjects with no significant nausea overall

  7 weeks

• the proportion of subjects with CR in the 24 hours following initiation of radiotherapy and concomitant cisplatin

  24 hours

Other Outcomes (1)

• Progress-free survival (PFS)

  1 year

Study Arms (2)

Weekly Arm

EXPERIMENTAL

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

Drug: fosaprepitant

Triweekly Arm

ACTIVE COMPARATOR

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

Drug: fosaprepitant

Interventions

fosaprepitant DRUG

fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy

Triweekly Arm; Weekly Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Yang Q, Zou X, Xie YL, Lin C, Ouyang YF, Liu YL, Duan CY, You R, Liu YP, Liu RZ, Huang PY, Guo L, Hua YJ, Chen MY. Fosaprepitant Weekly vs Every 3 Weeks for the Prevention of Concurrent Chemoradiotherapy-Induced Nausea and Vomiting: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2326127. doi: 10.1001/jamanetworkopen.2023.26127.

  PMID: 37498596 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

fosaprepitant

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ming-Yuan Chen, MD,PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 19, 2020
• Study Start: November 24, 2020
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

CN (1)