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| Name | Class |
|---|---|
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| 303rd Hospital of the People's Liberation Army | OTHER |
| Nanning Second People's Hospital | OTHER |
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This study is a multicenter trial.The primary objective is to estimate short-term efficacy and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma.
Secondary objectives are to evaluate the overall survival, the distant metastases free survival, and disease free survival of patients with locoregionally advanced nasopharyngeal carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.
Patients with clinical stage T3-4N1/N2-3 (UICC 7th edition)are divided into two groups according to informed consent:intensity-modulated radiation therapy(IMRT)group and conventional fractionation radiotherapy(CRT)group. Then the patients in IMRT group/CRT group are randomly assigned to receive nedaplatin+docetaxel in neoadjuvant chemotherapy plus nedaplatin alone in concurrent chemoradiotherapy or cisplatin+docetaxel in neoadjuvant chemotherapy plus cisplatin alone in concurrent chemoradiotherapy.Evaluate the overall survival, the distant metastases free survival, and disease free survival of the patients treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1A(nedaplatin and IMRT) | Experimental | neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT) |
|
| 1B(cisplatin and IMRT) | Active Comparator | neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT) |
|
| 2A(nedaplatin and CRT) | Experimental | neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT) |
|
| 2B((cisplatin and CRT)) | Active Comparator | neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nedaplatin and docetaxel | Drug | neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| complete response (CR) rate | 3 months after treatment | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicities | Acute toxicity will be measured by CTCAE3.0 | 2 years |
| Overall Survival | 1 years,3 years and 5 years overall survival,disease free survival,distant metastases free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang R Sheng, M.D. | Contact | 86(0771)3276223 | wrsgx@yahoo.com.cn | |
| Wu Fang, M.D. | Contact | 86(0771)3276313 | 96160f@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wang R. sheng, M.D. | Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University | Study Chair |
| Wang R sheng, M.D. | Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
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| Guangxi Traditional Chinese Medical University |
| OTHER |
| Guilin Medical College | OTHER |
| Guangxi Naxishan Hospital | OTHER |
| Liuzhou Workers' Hospital | OTHER_GOV |
| LiuZhou People's Hospital | OTHER |
| Liuzhou Hospital of Traditional Chinese Medicine | OTHER |
| Liuzhou Cancer Hospital | UNKNOWN |
| Liuzhou Railway hospital | UNKNOWN |
| First People's Hospital of Yulin | OTHER |
| The Red Cross hospital of YuLin | UNKNOWN |
| Guigang People's Hospital | OTHER |
| Wuzhou Red Cross Hospital | OTHER |
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|
| cisplatin and docetaxel | Drug | neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy |
|
|
| nedaplatin and docetaxel | Drug | neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy |
|
|
| cisplatin and docetaxel | Drug | neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy |
|
|
| 1,3,5 years |
| cost-effectiveness ratio | Calculate the cost(C) and complete response rate(E) of each group 3 months after treatment,then calculate cost-effectiveness ratio(C/E). | 3 months |
| Wu Fang, M.D. | Department of Radiotherapy,the First Affiliated Hospital of Guangxi Medical University | Principal Investigator |
| 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 |
|---|---|
| C053989 | nedaplatin |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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