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| Name | Class |
|---|---|
| Jiangxi Provincial Cancer Hospital | OTHER |
| Zhejiang Cancer Hospital | OTHER |
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This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the efficacy and safety of sufficient chemoradiotherapy plus oral capecitabine/S-1 for 1 year in the treatment of oligometastatic Nasopharyngeal Carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufficient Chemotherapy Combine With Maintenance Chemotherapy | Experimental | Patients with oligometastatic Nasopharyngeal Carcinoma was given S-1 40-60mg bid d1-14, q4w, oral maintenance chemotherapy for 1 year or capecitabine 2500mg/m2/d twice daily oral d1-14, q4w after receiving sufficient chemotherapy and consolidative local therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine/S-1 | Drug | Drug: Capecitabine/S-1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival(PFS) | PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | 12 months and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | OS was defined as the time from randomization to death from any cause | 12 months and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaojun Lin, DR | Contact | 8613860603879 | linshaojun@yeah.net | |
| Qiaojuan Guo, DR | Contact | 8615080013157 | guoqiaojuan@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of radiation oncology, Fujian cancer hospital | Fuzhou | Fujian | 350014 | China |
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| Chemotherapy | Drug | Gemcitabine (1000mg/m2) D1 D8+ nidaplatinum (80-100mg/m2) D2 q3w ×4-6cycle |
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| Head and neck radiotherapy | Radiation | IMRT is uesd for the synchronous oligometastatic Nasopharyngeal Carcinoma; |
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| Local Consolidative Therapy | Other | radiotherapy,surgery or interventional therapy for all metastatic sites. |
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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 |
| 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 |
|---|---|
| D060046 | Maintenance Chemotherapy |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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