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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.
This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. This is a multicenter study. All patients will be enrolled in endemic area. All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is objective response rate (ORR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNF-N | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel, nedaplatin, fluorouracil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | CR+PR | at the end of radiotherapy(±1week) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | The OS was defined as the duration from the date of beginning of treatment to the date of death from any cause or censored at the date of the last follow-up. | 3 years |
| Progress-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinquan Liu, M.D | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical Universityedical University | Guangzhou | Guangdong | 510095 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41496409 | Derived | Chen 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. |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C053989 | nedaplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| IMRT | Radiation | 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. |
|
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| Nedaplatin | Drug | Concurrent chemotherapy. nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy. |
|
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Progress-free survival is calculated from the date of beginning of treatment to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
| 3 years |
| Locoregional Relapse-Free Survival(LRRFS) | Relapse-free survival was defined as the time from beginning of treatment to local or regional relapse, or death from any cause. | 3 years |
| Distant metastasis-Free Survival(DMFS) | Distant metastasis-free survival was defined as the time from beginning of treatment to distant metastasis, or death from any cause. | 3 years |
| Quality of life (QoL) | Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for head and neck (EORTC QLQ-H&N35). The EORTC QLQ-H&N35 scale employs a 4-point response format ("not at all" to "very much"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the functioning and the global QoL scale, a higher score indicates better health. For the symptom scales, a higher score indicates a higher level of symptom burden. Either English or Chinese version will be used according to patient's language habits. | 3 years |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |