Status:
UNKNOWN
Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangdong Provincial People's Hospital
Conditions:
Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 ca...
Detailed 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 \- A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 11 2024
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT03837808
Start Date
April 11 2019
End Date
February 11 2024
Last Update
November 7 2022
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060