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Docetaxel

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Induction docetaxel, cisplatin, and fluorouracil plus concurrent chemoradiotherapy with cisplatin

Induction docetaxel, nedaplatin, and fluorouracil plus concurrent chemoradiotherapy with nedaplatin

Induction docetaxel, cisplatin, and capecitabine plus concurrent chemoradiotherapy with cisplatin

Induction docetaxel, nedaplatin, and capecitabine plus concurrent chemoradiotherapy with nedaplatin

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.

docetaxel, nedaplatin, and capecitabine

Patients receive concurrent nedaplatin (100mg/m2) every three weeks for two cycles during radiotherapy.

nedaplatin

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.

docetaxel, cisplatin, and fluorouracil

Patients receive concurrent cisplatin (100mg/m2) every three weeks for two cycles during radiotherapy.

cisplatin

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, cisplatin, and capecitabine

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.

docetaxel, nedaplatin, and fluorouracil

Jun Ma, M.D.

Principal Investigator Principal Investigator, M.D.

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).

In this study, patients with non-keratinizing NPC and staged III-IVA (except T3-4N0) are randomly assigned to one of the four groups: Group A: TPF+P-RT; Group B: TNF+N-RT; Group C: TPX+P-RT; Group D: TNX+N-RT. In induction chemotherapy, patients will receive docetaxel(60 mg/m2 on day 1), cisplatin or nedaplatin (60 mg/m2 on day 1) and fluorouracil (600 mg/m2 on Days 1 to 5) or capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radical radiotherapy. Concurrent cisplatin or nedaplatin (100mg/m2 on day 1) was given every three weeks for two cycles during radiotherapy. Patients are stratified according to the treatment centers and stage. The primary endpoint is progression-free survival (PFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), toxic effects, and quality of life (QOL). All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC

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

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

Overall survival is calculated from randomization to death from any cause.

Distant failure-free survival is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.

Locoregional failure-free survival is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC	NCT03503136	Nasopharyngeal ...	docetaxel, neda... nedaplatin docetaxel, cisp... cisplatin docetaxel, cisp... docetaxel, neda...	18 Years - 60 Years	Sun Yat-sen University
Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC	NCT03503136	Nasopharyngeal ...	docetaxel, neda... nedaplatin docetaxel, cisp... cisplatin docetaxel, cisp... docetaxel, neda...	18 Years - 60 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for docetaxel, nedaplatin, and capecitabine