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NOT YET RECRUITING
NCT03503136
PHASE3

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

nedaplatin

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

DRUG

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.

DRUG

cisplatin

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

DRUG

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.

DRUG

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