Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Randomized Phase III Non-inferiority Study of Radiotherapy Plus Concurrent Nimotuzumab Versus Cisplatin in Stage II-III Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03837808
• Other study ID #: 2018-FXY-206
• Status: Recruiting
• Phase: Phase 3
• Start date: April 11, 2019
• Est. completion date: February 11, 2024

Study information

• Verified date: November 2022
• Source: Sun Yat-sen University
• Contact: Ming-Yuan Chen, MD,PhD
• Phone: +86-20-87343361
• Email: chenmy[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III nasopharyngeal carcinoma.

Description:

Scheme:

Eligible stage II and III NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.

• Arm Cisplatin: cisplatin 40mg/m2/week in concurrent with IMRT

• Arm nimotuzumab: nimotuzumab 200mg/week in concurrent with IMRT

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: February 11, 2024
• Est. primary completion date: February 11, 2024
• 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

• histologically confirmed positive EGFR expression

• Stage II and III NPC patients(according to the 8th AJCC edition)

• Male and no pregnant female

• Age between 18-65

• 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

• History of prior malignancy or previous treatment for NPC

• 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.

• Pregnancy or lactation

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Neoplasm
• Head and Neck Neoplasms
• Nasopharyngeal Carcinoma
• Nasopharyngeal Diseases
• Nasopharyngeal Neoplasms
• Neoplasms

Intervention

Drug:
• Nimotuzumab
nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
• Cisplatin
cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-sen University	Affiliated Cancer Hospital & Institute of Guangzhou Medical University, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival (PFS)	Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.	2 years
Secondary	Overall Survival (OS)	The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.	2 years
Secondary	Locoregional Relapse-Free Survival (LRRFS)	The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.	2 years
Secondary	Distant Metastasis-Free Survival (DMFS)	The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.	2 years
Secondary	Number of participants with adverse events		up to 2 years