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At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy | Experimental | Four cycles of neoadjuvant chemotherapy combined with radical radiotherapy |
|
| 3cycles of Neoadjuvant Chemotherapy With chemoradiotherapy | Active Comparator | 3 cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy | Drug | 4 Cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy, instead of Concurrent Chemoradiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | the duration between the date of diagnosed and date of patient death | 5 years |
| 5-year metastatic free survival | the duration between the date of diagnosed and date of metastasis | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year disease-free survival | the duration between the date of diagnosed and date of related disease | 5 years |
| 5-year recurrence-free survival | the duration between the date of diagnosed and date of recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qichun Wei | Contact | 0571-87783522 | qichun_wei@zju.edu.cn | |
| Jing Xu | Contact | 0571-87783522 | shanyefengxu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qichun Wei | 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Not yet recruiting | Fuzhou | Fujian | 350001 | China |
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| 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy | Drug | 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy, instead of definitive radiotherapy |
|
| 5 years |
| Safety (incidence of grade 3/4 adverse reactions) | treatment related toxic effects | 5 years |
| Cancer prevention and treatment center, sun yat-sen university | Not yet recruiting | Guandong | Guangdong | 510060 | China |
|
| The first affiliated hospital, college of medicinle, Zhejiang University | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
|
| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
|
| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China | Recruiting | Hangzhou | Zhejiang | 310058 | China |
|
| Zhejiang Xiaoshan Hospital | Not yet recruiting | Hangzhou | Zhejiang | 311200 | China |
|
| Jinhua Central Hospital | Not yet recruiting | Jinhua | Zhejiang | 321000 | China |
|
| Lishui City Central Hospital | Not yet recruiting | Lishui | Zhejiang | 323000 | China |
|
| Ningbo Yinzhou People's Hospital | Not yet recruiting | Ningbo | Zhejiang | 315000 | China |
|
| Ningbo No.2 Hospital | Not yet recruiting | Ningbo | Zhejiang | 315010 | China |
|
| People's Hospital of Quzhou | Not yet recruiting | Quzhou | Zhejiang | 324000 | China |
|
| 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 |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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