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

Sponsors

Lead Sponsor: Sun Yat-sen University

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

Source Sun Yat-sen University
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

Overall Status Recruiting
Start Date 2019-04-11
Completion Date 2024-02-11
Primary Completion Date 2022-02-11
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Progress-free survival (PFS) 2 years
Secondary Outcome
Measure Time Frame
Overall Survival (OS) 2 years
Locoregional Relapse-Free Survival (LRRFS) 2 years
Distant Metastasis-Free Survival (DMFS) 2 years
Number of participants with adverse events up to 2 years
Enrollment 384
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nimotuzumab

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

Arm Group Label: Nimotuzumab

Intervention Type: Drug

Intervention Name: Cisplatin

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

Arm Group Label: Cisplatin

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

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Ming-Yuan Chen, MD,PhD Principal Investigator Sun Yat-sen University
Overall Contact

Last Name: Ming-Yuan Chen, MD,PhD

Phone: +86-20-87343361

Email: [email protected]

Location
Facility: Status: Contact: Sun Yat-sen University Cancer Center Rui-Hua Xu, MD,PhD
Location Countries

China

Verification Date

2021-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Sun Yat-sen University

Investigator Full Name: Ming-Yuan Chen

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Nimotuzumab

Type: Experimental

Description: nimotuzumab 200mg/week in concurrent with IMRT

Label: Cisplatin

Type: Active Comparator

Description: cisplatin 40mg/m2/week in concurrent with IMRT

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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