NCT03557112

By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy for Locally Advanced NPC

Prospective, Multicenter, and Nonrandomized Phase II Clinical Study on the Treatment of Locally Advanced NPC By Comparing TPF Induction Chemotherapy Combined With Nimotuzumab Concurrent Radiotherapy and Cisplatin Concurrent Radio-chemotherapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Guiyang Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is aimed to investigate the short-term efficacy and toxicities of local advanced nasopharyngeal carcinoma (NPC) treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and cisplatin concurrent chemoradiotherapy.

Detailed description

TPF program is currently the local advanced nasopharyngeal carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy, however, due to heavier gastrointestinal reactions caused by cisplatin， direct damage to renal parenchymal and other adverse reactions often lead to anti-tumor therapy can not be smooth Carried out, resulting in treatment failure, thus affecting the survival of patients.In this study, Phase II clinical trials were performed. Patients with locally advanced local advanced nasopharyngeal carcinoma were nonrandomly divided into experimental group and control group.The trial group was treated with TPF regimen induction chemotherapy combined with nimotuzumab concurrent radiotherapy and chemotherapy. The control group was treated with TPF regimen induction chemotherapy combined with Cisplatin concurrent radiotherapy and chemotherapy.observed and compared the efficacy and toxicity of the two treatment to assess its safety and patient tolerance.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Nimotuzumab	TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
DRUG	Cisplatin	TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy

Timeline

• Start date: 2018-06-01
• Primary completion: 2021-06-01
• Completion: 2021-12-01
• First posted: 2018-06-14
• Last updated: 2018-11-02

Locations

1 site across 1 country: China