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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 radical chemoradiotherapy plus oral capecitabine/teggio for 1 year in patients with N3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radical chemoradiotherapy plus oral capecitabine/teggiol | Experimental | Patients with newly diagnosed, non-metastatic stage N3 NPC was given Teggio 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 radical chemoradiotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine/Tiggio | Drug | Drug: Capecitabine/Tiggio Radical chemoradiotherapy:Induction chemotherapy plus Concurrent chemoradiotherapy Induction chemotherapy:Gemcitabine (1000mg/m2) D1 D8+ nida platinum (80mg/m2) D2 q3w ×3cycle Concurrent chemoradiotherapy:IMRT was used for radiotherapy, during which D1 and D22 were given two cycles of single drug concurrent chemotherapy with nidapatin (100mg/m2). |
| 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. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaojun Lin, DR | Contact | 13860603879 | linshaojun@yeah.net | |
| Jingfeng Zong, DR | Contact | 13365910013 | zongjingfeng@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of radiation oncology, Fujian cancer hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42260486 | Derived | Lin X, Huang L, Zheng J, Chen B, Huang C, Chen L, Pan C, Guo Q, Lin S, Zong J. Efficacy and safety of schedule-modified oral capecitabine/S-1 as maintenance therapy for stage N3 nasopharyngeal carcinoma after definitive chemoradiotherapy: a multicentre, single-arm phase II clinical trial. BMC Oral Health. 2026 Jun 9. doi: 10.1186/s12903-026-08865-8. Online ahead of print. |
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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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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
|
| 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D055585 | Physical Phenomena |