Clinical trial · Interventional
Nedaplatin in Treatment for Nasopharyngeal Carcinoma
Induction Chemotherapy With Nedaplatin, Docetaxel and 5-Fluorouracil Followed by Concurrent Nedaplatin and Radiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Single Arm, Open Label, Multicenter, Phase II Clinical Study.
NCT04834206CI-TRIAL-00058384completedPhase 2ClinicalTrials.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 evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel, nedaplatin, fluorouracil | Drug | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
| Nedaplatin | Drug | Nedaplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- 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
- Radiation: IMRT
- Drug: Nedaplatin
Primary outcomes (1)
- measure
- objective response rate (ORR)
- timeFrame
- at the end of radiotherapy(±1week）
- description
- CR+PR
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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: * Treatment with palliative intent * The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes) * 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.
References
Publications (1)
- DERIVEDChen FZ, Deng Y, Yin WJ, Wang MY, Yang F, Yang ZH, Zhou LP, Chen SD, Chen JL, Jiang XZ, Zhou AX, Ou YM, Liu JQ, Chen DP, Qi B. Induction chemotherapy with nedaplatin, docetaxel and 5-fluorouracil followed by concurrent nedaplatin and radiotherapy in locoregionally advanced nasopharyngeal carcinoma: A single arm, open label, phase II clinical trial. Transl Oncol. 2026 Feb;64:102634. doi: 10.1016/j.tranon.2025.102634. Epub 2026 Jan 6. PMID 41496409