Clinical trial NCT03837808: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Nasopharyngeal Diseases
Head and Neck Neoplasm
Keywords: nimotuzumab
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Guangdong Provincial People's Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2019-02-12
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Progress-free survival (PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Locoregional Relapse-Free Survival (LRRFS)
timeFrame: 2 years
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: 2 years
measure: Number of participants with adverse events
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming-Yuan Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: