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This is a randomized,controlled,prospective phase III clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent chemoradiation + adjuvant chemotherapy | Experimental | IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy |
|
| Concurrent chemoradiation | Active Comparator | IMRT combine with cisplatin concurrent chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMRT combine with cisplatin concurrent chemotherapy | Drug | Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT. |
| Measure | Description | Time Frame |
|---|---|---|
| Distant metastasis-free survival | Defined as the time from date of recruitment to documented distant metastasis or death from any cause. | Five year |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival | Defined as the time from date of recruitment to documented relapse or death from any cause. | Five year |
| Locoregional relapse-free survival | Defined as the time from date of recruitment to documented locoregional relapse or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| zhao chong, M.D | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Sun Yat-sen University | Guangzhou | Guangdong | China |
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| Label | URL |
|---|---|
| Home Page of Cancer Center, Sun Yat-sen University | View source |
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| IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy | Drug | Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT. |
|
| Five year |
| Overall survival | Defined as the time from date of recruitment to death from any cause. | Five year |
| Acute toxicity | Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0) for chemotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities. | three months after corresponding treatment |
| Late toxicity | Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria. | Five year |
| 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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