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| Name | Class |
|---|---|
| Guilin Hospital of Traditional Chinese Medicine | UNKNOWN |
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The study is to observe the efficacy and toxicity of demethylating drug decitabine and cisplatin induced chemotherapy for 3 cycles followed by concurrent chemoradiotherapy in the treatment of regionally advanced nasopharyngeal carcinoma,followed up for 2 years, observing the 2-year survival rate and variation of degrees of methylation before and after treatment,providing clinical basis for the clinical study of stage II-III.
Recent studies and previous studies in the investigator's research group have found that nasopharyngeal carcinoma is a disease with hypermethylation changes, and epigenetic treatment has not yet been carried out in nasopharyngeal carcinoma. In this study, Simon's two-stage design method was used to select 30 patients with nasopharyngeal carcinoma, treated with demethylating drug decitabine 7mg/m2 d1-5 + cisplatin 80mg/m2 d1 induced chemotherapy for 3 cycles followed by concurrent chemoradiotherapy with cisplatin 80mg/m2. observing the efficacy and toxicity of decitabine in the treatment of regionally advanced nasopharyngeal carcinoma, followed up for 2 years, observing the 2-year survival rate,evluating the relationship between different degrees of methylation and survival before and after treatment,provide clinical basis for the clinical study of stage II-III.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| decitabin and cisplatin induced chemotherapy followed by CC | Experimental | Treated by demethylated drug decitabine injection combined with cisplatin induced chemotherapy followed by concurrent chemoradiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Demethylated drug decitabine | Drug | Induced treatment by demethylating drug decitabine 7mg/m2 d1-5 and cisplatin 80mg/m2 d1 for 3 cycles to regionally advanced nasopharyngeal carcinoma followed by concurrent chemoradiotherapy with cisplatin 80mg/m2 d1 for 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The time from the first day of therapy to death or last follow-up | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from the first day of therapy to death or last follow-up | 2 years |
| Locoregional recurrence-free survival | The time from the first day of therapy to death or last follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongjun Zhang, Master | Contact | +86-18977330177 | 41974954@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Jiang, PhD | Guilin Medical University, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guilin Hospital of Traditional Chinese Medicine | Recruiting | Guilin | Guangxi | 541002 | China |
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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 |
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| 2 years |
| Distant metastasis-free survival | The time from the first day of therapy to death or last follow-up | 2 years |
| Dgree of methylation Carcinoma | The variations of the dgree of methylation before and after 2 months treatment | 2 months |
| Treatment toxicity | The time from the first day of therapy to death or last follow-up | 2moths to 2 years |
| Guilin Medical University | Recruiting | Guilin | Guangxi | China |
|
| 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 |