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| Name | Class |
|---|---|
| Jiangxi Provincial Cancer Hospital | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| National Cancer Centre, Singapore | OTHER |
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This is an randomized controlled, multicenter 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 high risk nasopharyngeal carcinoma.
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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) every three weeks for three cycles during RT. |
| Measure | Description | Time Frame |
|---|---|---|
| Failure free survival | Defined as the time from date of recruitment to documented relapse or death from any cause. | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicity | To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional relapse free survival | Defined as the time from date of recruitment to documented locoregional relapse or death from any cause. | 3-year |
| Distance metastasis free survival | Defined as the time from date of recruitment to documented distant metastatic recurrence or death from any cause. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| zhao chong, M.D | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center, Sun Yat-sen University | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40890288 | Derived | Liu Y, Yan W, Chen Y, Miao J, Zhang H, Wang J, Zhang Y, Huang X, Wang K, Qu Y, Chen X, Zhang J, Luo J, Li YX, Zhao C, Ma J, Wu R, Yi J. Treatment response-adapted risk index model for survival prediction and adjuvant chemotherapy selection in nonmetastatic nasopharyngeal carcinoma. NPJ Digit Med. 2025 Sep 1;8(1):564. doi: 10.1038/s41746-025-01918-2. | |
| 36227615 |
| 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) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles. |
|
| 3-year |
| Overall survival rate | Defined as the time from date of recruitment to death from any cause. | 3-year |
| Late Toxicity | To evaluate the late toxicity with the RTOG/EORTC criterion when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used. | 3 years |
| Miao J, Wang L, Tan SH, Li JG, Yi J, Ong EHW, Tan LLY, Zhang Y, Gong X, Chen Q, Xiang YQ, Chen MY, Guo Y, Lv X, Xia WX, Tang L, Deng X, Guo X, Han F, Mai HQ, Chua MLK, Zhao C. Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Oct 13;8(12):1776-85. doi: 10.1001/jamaoncol.2022.4656. Online ahead of print. |
| 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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