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

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Nasopharyngeal Carcinoma; Head and Neck Neoplasm; Nasopharyngeal Diseases; Nasopharyngeal Neoplasms

Treatments: Drug: Cisplatin; Drug: Nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03837808

2018-FXY-206

Details and patient eligibility

About

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.

Full 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

Enrollment: 384 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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384 participants in 2 patient groups

Nimotuzumab

Experimental group

Description:

nimotuzumab 200mg/week in concurrent with IMRT

Treatment:

Drug: Nimotuzumab

Cisplatin

Active Comparator group

Description:

cisplatin 40mg/m2/week in concurrent with IMRT

Treatment:

Drug: Cisplatin