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To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNF-N | Experimental |
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| DPF-P | Active Comparator |
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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 |
|---|---|---|
| Progress-Free Survival (PFS) | Progress-free survival is calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up. | 3 years |
| Locoregional Relapse-Free Survival(LRRFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinquan Liu, M.D | Contact | 0086-137-1086-6485 | 609149209@qq.com | |
| Bin Qi, M.D | Contact | 0086-135-8058-0985 | qibin020@126.com |
| 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 University | Recruiting | Guangzhou | Guangdong | 510095 | China |
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| Docetaxel, cisplatin, fluorouracil | Drug | 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. |
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| Nedaplatin | Drug | Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy. |
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| Cisplatin | Drug | Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy. |
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| Intensity modulated-radiotherapy | 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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Relapse-free survival was defined as the time from random assignment 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 random assignment 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 |
| Objective Response Rate (ORR) | Objective Response Rate (ORR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1) | 12 weeks after the interventions |
| Disease Control Rate (DCR) | Disease Control Rate (DCR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1) | 12 weeks after the interventions |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| 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 |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C053989 | nedaplatin |
| D005472 | Fluorouracil |
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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