Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in Induction Chemotherapy Plus Concurrent Chemoradiotherapy for Locoregionally Advanced NPC： a Phase 3, Multicentre, Non-inferiority, Randomised Factorial Trial (NX-NPC)

NCT03503136 Phase 3 NOT_YET_RECRUITING

This is a phase 3, multicentre, non-inferiority, randomised factorial trial. The purpose of this study is to study the efficacy and safety of nedaplatin versus cisplatin, and capecitabine versus fluorouracil in induction docetaxel, cisplatin, and fluorouracil (TPF) plus concurrent chemoradiotherapy with cisplatin (P-RT) in locoregionally advanced nasopharyngeal carcinoma (NPC).

Details

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	632
Start date	2018-06
Completion	2026-06

Conditions

• Nasopharyngeal Carcinoma

Interventions

• docetaxel, nedaplatin, and capecitabine
• nedaplatin
• docetaxel, cisplatin, and fluorouracil
• cisplatin
• docetaxel, cisplatin, and capecitabine
• docetaxel, nedaplatin, and fluorouracil

Primary outcomes

• Progression-free survival — 3 years
  Progression-free survival is calculated from the date of randomisation to the date of disease progression or death from any cause, whichever is first.

Countries

China