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| Name | Class |
|---|---|
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| Affiliated Cancer Hospital of Shantou University Medical College | OTHER |
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This multicenter, randomised, phase 3 study is to evaluate the survival benefit of maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.
Firstly diagnosed metastatic nasopharyngeal carcinoma patients will receive 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine. After disease controlled, they will be randomly assigned to maintenance capecitabine plus best supportive care(BSC) or BSC alone. The primary end point is progression-free survival, the secondary end points are overall survival, duration of response, objective response rate, adverse effects and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maintenance capecitabine | Experimental | maintenance capecitabine plus best supportive care(BSC) |
|
| best supportive care | Other | Best supportive care and following-up every 6-8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug | capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | the time from randomization to the progression of disease | up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | the time from randomization to death | up to 6 years |
| duration of response | the time from the date of the first cycle of chemotherapy to the progression of disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiang Guo, MD | Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SunYat-senU | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22684794 | Background | Jin Y, Shi YX, Cai XY, Xia XY, Cai YC, Cao Y, Zhang WD, Hu WH, Jiang WQ. Comparison of five cisplatin-based regimens frequently used as the first-line protocols in metastatic nasopharyngeal carcinoma. J Cancer Res Clin Oncol. 2012 Oct;138(10):1717-25. doi: 10.1007/s00432-012-1219-x. Epub 2012 Jun 10. | |
| 22076785 | Background |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| Best supportive care (BSC) | Other | Best supportive care and following-up every 6-8 weeks |
|
| up to 6 years |
| objective response rate | CR, PR and SD rate | up to 6 years |
| adverse effects | chemotherapy side effects | up to 6 years |
| quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care | evaluate with FACT-H&N every 3 months after randomiztion | up to 6 years |
| Chua DT, Yiu HH, Seetalarom K, Ng AW, Kurnianda J, Shotelersuk K, Krishnan G, Hong RL, Yang MH, Wang CH, Sze WK, Ng WT. Phase II trial of capecitabine plus cisplatin as first-line therapy in patients with metastatic nasopharyngeal cancer. Head Neck. 2012 Sep;34(9):1225-30. doi: 10.1002/hed.21884. Epub 2011 Nov 11. |
| 18615622 | Background | Leong SS, Wee J, Rajan S, Toh CK, Lim WT, Hee SW, Tay MH, Poon D, Tan EH. Triplet combination of gemcitabine, paclitaxel, and carboplatin followed by maintenance 5-fluorouracil and folinic acid in patients with metastatic nasopharyngeal carcinoma. Cancer. 2008 Sep 15;113(6):1332-7. doi: 10.1002/cncr.23687. |
| 36777769 | Derived | Han J, Lan X, Tian K, Shen X, He J, Chen N. Cost-effectiveness analysis of capecitabine maintenance therapy plus best supportive care vs. best supportive care alone as first-line treatment of newly diagnosed metastatic nasopharyngeal carcinoma. Front Public Health. 2023 Jan 26;10:1086393. doi: 10.3389/fpubh.2022.1086393. eCollection 2022. |
| 35175316 | Derived | Liu GY, Li WZ, Wang DS, Liang H, Lv X, Ye YF, Zhao C, Ke LR, Lv SH, Lu N, Bei WX, Cai ZC, Chen X, Liang CX, Guo X, Xia WX, Xiang YQ. Effect of Capecitabine Maintenance Therapy Plus Best Supportive Care vs Best Supportive Care Alone on Progression-Free Survival Among Patients With Newly Diagnosed Metastatic Nasopharyngeal Carcinoma Who Had Received Induction Chemotherapy: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):553-561. doi: 10.1001/jamaoncol.2021.7366. |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |