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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03837808

Enrollment

384

Registered

2019-02-12

Start date

2019-04-11

Completion date

2024-02-11

Last updated

2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

nimotuzumab

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

Interventions

DRUGNimotuzumab

nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT

DRUGCisplatin

cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Progress-free survival (PFS)	2 years	Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

Secondary

Measure	Time frame	Description
Overall Survival (OS)	2 years	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.
Locoregional Relapse-Free Survival (LRRFS)	2 years	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.
Distant Metastasis-Free Survival (DMFS)	2 years	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.
Number of participants with adverse events	up to 2 years	—

Countries

China

Contacts

Primary ContactMing-Yuan Chen, MD,PhD

chenmy@sysucc.org.cn+86-20-87343361

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026