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GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinomaļ¼ša Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial

Clinical Trial Summary

The purpose of this study is to compare the survival and toxicity of GP (gemcitabine and cisplatin) vs. PF (cisplatin and fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma( NPC ) patients.

Clinical Trial Description

Patients presented with non-keratinizing NPC and stage T1-4N2-3/T4N0-1M0 are randomly assigned to receive GP (gemcitabine and cisplatin) or PF (cisplatin and fluorouracil) induction chemotherapy combined with concurrent chemoradiotherapy. Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m²) every three weeks for two cycles during radiotherapy. Patients in the investigational arm receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Patients in the control arm receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Our primary endpoint is progress-free survival (PFS). Secondary end points include distant metastasis-free survival (DMFS), overall survival (OS), locoregional relapse-free survival (LRRFS), initial response rates after treatments, toxic effects and quality of life (QoL). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03840421
Study type Interventional
Source Sun Yat-sen University
Contact
Status Active, not recruiting
Phase Phase 3
Start date April 3, 2019
Completion date December 31, 2028
View Details
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