NCT03837808

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DRUG	Nimotuzumab	nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
DRUG	Cisplatin	cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT

Timeline

• Start date: 2019-04-11
• Primary completion: 2024-02-11
• Completion: 2024-02-11
• First posted: 2019-02-12
• Last updated: 2022-11-07

Locations

1 site across 1 country: China