Brief Title
Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma
Official Title
A Randomized Phase III Non-inferiority Study of Radiotherapy Plus Concurrent Nimotuzumab Versus Cisplatin in Stage II-III Nasopharyngeal Carcinoma
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 carcinoma.
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 - Arm nimotuzumab: nimotuzumab 200mg/week in concurrent with IMRT
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progress-free survival (PFS)
Secondary Outcome
Overall Survival (OS)
Condition
Nasopharyngeal Carcinoma
Intervention
Nimotuzumab
Study Arms / Comparison Groups
Nimotuzumab
Description: nimotuzumab 200mg/week in concurrent with IMRT
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
384
Start Date
April 11, 2019
Completion Date
February 11, 2024
Primary Completion Date
February 11, 2022
Eligibility 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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Ming-Yuan Chen, MD,PhD, +86-20-87343361, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03837808
Organization ID
2018-FXY-206
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study Sponsor
Ming-Yuan Chen, MD,PhD, Principal Investigator, Sun Yat-sen University
Verification Date
July 2019