Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma
NCT04437329 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352
Last updated 2022-05-10
Summary
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Conditions
- Nasopharyngeal Carcinoma
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
-
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.
Sponsors & Collaborators
-
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
lead OTHER
Principal Investigators
-
Jinquan Liu, M.D · Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-01
- Primary Completion
- 2028-06-30
- Completion
- 2029-06-30
Countries
- China
Study Locations
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