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RECRUITING
NCT04437329
PHASE3

Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.

Official title: Nedaplatin Versus Cisplatin in Induction Chemotherapy Combined With Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma:a Prospective, Parallel, Randomized, Open Labeled, Phase III Non-Inferiority Clinical Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2020-08-01

Completion Date

2029-06-30

Last Updated

2022-05-10

Healthy Volunteers

No

Interventions

DRUG

Docetaxel, nedaplatin, fluorouracil

Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.

DRUG

Docetaxel, cisplatin, fluorouracil

Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.

DRUG

Nedaplatin

Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.

DRUG

Cisplatin

Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.

RADIATION

Intensity modulated-radiotherapy

Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.

Locations (1)

Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China