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The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC plus RT | Experimental | Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m^2) every three weeks for three cycles during radiotherapy. |
|
| IC plus CCRT | Active Comparator | Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil | Drug | Patients receive GP gemcitabine (1000 mg/m^2 d1,8) and cisplatin (80mg/m^2 d1) or TPF docetaxel (60mg/m^2 on day 1), cisplatin (60mg/m^2 on day 1) and fluorouracil (600mg/m^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Disease-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first. | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival is calculated from randomization to death from any cause. | 3-year |
| Locoregional recurrence-free survival | Locoregional recurrence-free survival is calculated from randomization to the first locoregional recurrence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingchen Peng, MD, PhD | Contact | +86 18980606753 | pxx2014@scu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xingchen Peng, MD, PhD | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xingchen Peng | Chengdu | Sichuan | 610041 | China |
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|
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| IMRT | Radiation | Intensity modulated-radiotherapy (IMRT) is given as 2.0 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. |
|
| IMRT and concurrent cisplatin | Radiation | Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 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, concurrently with cisplatin 100 mg/m^2 every 3 weeks for 3 cycles. |
|
| 3-year |
| Distant metastasis-free survival | Distant metastasis-free survival is calculated from randomization to the first remote metastases. | 3-year |
| Objective response rates after treatments | At the end of Cycle 3 of induction chemotherapy (each cycle is 21 days) and 16 weeks after completion of radiotherapy |
| Number of participants with adverse events | Incidence of acute toxicity | Every week during treatment, up to 4 weeks after treatment. |
| 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 |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D005472 | Fluorouracil |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| 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 |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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