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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases, Head and Neck Neoplasm

Intervention / Treatment
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* Drug: Nimotuzumab
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nimotuzumab<br>nimotuzumab 200mg/week in concurrent with IMRT | Drug: Nimotuzumab<br>* nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT<br>|
| Active Comparator: Cisplatin<br>cisplatin 40mg/m2/week in concurrent with IMRT | Drug: Cisplatin<br>* cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Number of participants with adverse events |  | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nimotuzumab