Nedaplatin Versus Cisplatin in Treatment for Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Docetaxel, nedaplatin, fluorouracil, Docetaxel, cisplatin, fluorouracil, Nedaplatin, Cisplatin.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Detailed description
This is a prospective, parallel, randomized, open labeled, phase III, non-inferiority clinical trial to compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma patients in endemic area - nedaplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with nedaplatin as concurrent chemoradiotherapy (DNF-N) versus cisplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with cisplatin as concurrent chemoradiotherapy (DPF-P). All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is progress free survival (PFS).
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.
Primary outcome measures
- Progress-Free Survival (PFS) [Time frame: 3 years]
Secondary outcome measures (6)
- Overall Survival(OS) [Time frame: 3 years]
- Locoregional Relapse-Free Survival(LRRFS) [Time frame: 3 years]
- Distant metastasis-Free Survival(DMFS) [Time frame: 3 years]
- Quality of life (QoL) [Time frame: 3 years]
- Objective Response Rate (ORR) [Time frame: 12 weeks after the interventions]
- Disease Control Rate (DCR) [Time frame: 12 weeks after the interventions]
Eligibility criteria
Inclusion criteria
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
- No evidence of distant metastasis (M0)
- Age between 18-65
- WBC≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l
- With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
- With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
- Satisfactory performance status: KARNOFSKY scale (KPS) > 70
- Patients must give signed informed consent
Exclusion criteria
- Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I)
- Age >65 or < 18 years
- Treatment with palliative intent
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
- History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
- History of previous radiotherapy
- Pregnancy or lactation
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou — Guangzhou
Identifiers
NCT: NCT04437329 · NPC-NDP