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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03837808

Collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University (Other), Guangdong Provincial People's Hospital (Other), First Affiliated Hospital, Sun Yat-Sen University (Other)

384

Enrollment

Location

Arms

58.1

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma Nasopharyngeal Neoplasms Nasopharyngeal Diseases Head and Neck Neoplasm	Drug: Nimotuzumab Drug: Cisplatin	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

384 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 11, 2019

Anticipated Primary Completion Date :

Feb 11, 2022

Anticipated Study Completion Date :

Feb 11, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nimotuzumab nimotuzumab 200mg/week in concurrent with IMRT	Drug: Nimotuzumab nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
Active Comparator: Cisplatin cisplatin 40mg/m2/week in concurrent with IMRT	Drug: Cisplatin cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT

Arm

Intervention/Treatment

Experimental: Nimotuzumab

nimotuzumab 200mg/week in concurrent with IMRT

Drug: Nimotuzumab

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

Active Comparator: Cisplatin

cisplatin 40mg/m2/week in concurrent with IMRT

Drug: Cisplatin

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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