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

Primary Purpose

Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms, Nasopharyngeal Diseases

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Nimotuzumab

Cisplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring nimotuzumab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nimotuzumab

Cisplatin

Arm Description

nimotuzumab 200mg/week in concurrent with IMRT

cisplatin 40mg/m2/week in concurrent with IMRT

Outcomes

Primary Outcome Measures

Progress-free survival (PFS)

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)

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)

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)

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

Full Information

NCT ID

NCT03837808

First Posted

January 26, 2019

Last Updated

November 3, 2022

Sponsor

Sun Yat-sen University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03837808

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 11, 2019 (Actual)

Primary Completion Date

February 11, 2024 (Anticipated)

Study Completion Date

February 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

nimotuzumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nimotuzumab

Arm Type

Experimental

Arm Description

nimotuzumab 200mg/week in concurrent with IMRT

Arm Title

Cisplatin

Arm Type

Active Comparator

Arm Description

cisplatin 40mg/m2/week in concurrent with IMRT

Intervention Type

Drug

Intervention Name(s)

Nimotuzumab

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Progress-free survival (PFS)

Description

Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

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.

Time Frame

2 years

Title

Locoregional Relapse-Free Survival (LRRFS)

Description

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.

Time Frame

2 years

Title

Distant Metastasis-Free Survival (DMFS)

Description

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.

Time Frame

2 years

Title

Number of participants with adverse events

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming-Yuan Chen, MD,PhD

Phone

+86-20-87343361

chenmy@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming-Yuan Chen, MD,PhD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rui-Hua Xu, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

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

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