Radiotherapy Plus Concurrent Nimotuzumab or Cisplatin in Stage II-III Nasopharyngeal Carcinoma
NCT ID: NCT03837808
Last Updated: 2022-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
384 participants
INTERVENTIONAL
2019-04-11
2024-02-11
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nimotuzumab
nimotuzumab 200mg/week in concurrent with IMRT
Nimotuzumab
nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
Cisplatin
cisplatin 40mg/m2/week in concurrent with IMRT
Cisplatin
cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
Interventions
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Nimotuzumab
nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
Cisplatin
cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Guangdong Provincial People's Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Ming-Yuan Chen
Principal Investigator
Principal Investigators
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Ming-Yuan Chen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Rui-Hua Xu, MD,PhD
Role: primary
Other Identifiers
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2018-FXY-206
Identifier Type: -
Identifier Source: org_study_id
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