RecruitingPhase 3NCT04437329

Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma

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


Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Enrollment

352 participants

Start Date

Aug 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy drugs — nedaplatin and cisplatin — given alongside radiation therapy for people with nasopharyngeal carcinoma (a type of head and neck cancer). **You may be eligible if...** - You have a newly diagnosed, biopsy-confirmed nasopharyngeal cancer (non-keratinizing type) - Your cancer is stage III or IVa - You have not received any prior treatment for this cancer - You are between 18 and 65 years old **You may NOT be eligible if...** - You have the keratinizing type of nasopharyngeal cancer (WHO type I) - You are under 18 or over 65 years old - You have had another cancer in the past (except certain skin or early prostate cancers) - You have significant kidney, hearing, or nerve problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDocetaxel, 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.

DRUGDocetaxel, 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.

DRUGNedaplatin

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

DRUGCisplatin

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

RADIATIONIntensity 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

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NCT04437329


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