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

• Status: Recruiting
• Trial end date: 2024-02-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Affiliated Cancer Hospital & Institute of Guangzhou Medical University; First Affiliated Hospital, Sun Yat-Sen University; Guangdong General Hospital; Guangdong Provincial People's Hospital
• Treatments: Cisplatin; Nimotuzumab

Criteria

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