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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03837808
Other study ID # 2018-FXY-206
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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