Clinical trial · Interventional
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
NCT04437329CI-TRIAL-00058394recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel, cisplatin, fluorouracil | Drug | — | UNRESOLVED |
| Docetaxel, nedaplatin, fluorouracil | Drug | — | UNRESOLVED |
| Intensity modulated-radiotherapy | Radiation | — | UNRESOLVED |
| Nedaplatin | Drug | Nedaplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DNF-N
- description
- 1. Induction chemotherapy: three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks 2. Concurrent chemoradiotherapy: three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy
- interventionNames
- Drug: Docetaxel, nedaplatin, fluorouracil
- Drug: Nedaplatin
- Radiation: Intensity modulated-radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- DPF-P
- description
- 1. Induction chemotherapy: three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous cisplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks 2. Concurrent chemoradiotherapy: three cycles of 100 mg/m² cisplatin every 3 weeks, concurrently with intensity-modulated radiotherapy 3. Radiotherapy: radical intense modulated radiation therapy
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III 2. Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system 3. No evidence of distant metastasis (M0) 4. Age between 18-65 5. WBC≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l 6. With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln) 7. With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min) 8. Satisfactory performance status: KARNOFSKY scale (KPS) \> 70 9. Patients must give signed informed consent Exclusion Criteria: 1. Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I) 2. Age \>65 or \< 18 years 3. Treatment with palliative intent 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer 5. History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes 6. History of previous radiotherapy 7. Pregnancy or lactation 8. 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
References
Publications (0)
Data not yet available
No reference posted for this study.