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Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC
Sponsor: Sun Yat-sen University
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
632
Start Date
2018-06
Completion Date
2026-06
Last Updated
2018-05-11
Healthy Volunteers
No
Conditions
Interventions
docetaxel, nedaplatin, and capecitabine
Patients receive docetaxel(60 mg/m2 on day 1), nedaplatin (60 mg/m2 on day 1) and capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radiotherapy.
nedaplatin
Patients receive concurrent nedaplatin (100mg/m2) every three weeks for two cycles during radiotherapy.
docetaxel, cisplatin, and fluorouracil
Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
cisplatin
Patients receive concurrent cisplatin (100mg/m2) every three weeks for two cycles during radiotherapy.
docetaxel, cisplatin, and capecitabine
Patients receive docetaxel(60 mg/m2 on day 1), cisplatin (60 mg/m2 on day 1) and capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radiotherapy.
docetaxel, nedaplatin, and fluorouracil
Patients receive docetaxel (60mg/m2 on day 1), nedaplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China