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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Eye & ENT Hospital of Fudan University | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
| Jiangxi Provincial Cancer Hospital |
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The purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.
This is a phase 3 randomized clinical trial to determine the efficacy of maintenance chemotherapy for the treatment of metastatic chemotherapy and how it should be delivered. Participants will be randomized to 3 arms. Arm 1 (control group), participants will receive only conventional chemotherapy; arm 2 (experimental group), participants will receive up to 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3 (experimental group), after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities. Participants in all 3 arms will receive similar conventional chemotherapy. Four to eight cycles of conventional chemotherapy with platinum-based regimen is preferred. Maintenance chemotherapy should use one of the regimens: S1 (40mg, twice a day for 14 days, every 3 weeks), capecitabine (1000mg/m^2, twice a day for 14 days, every 3 weeks) or Tegafur-uracil (100mg/m^2, q8h, for 14 days, every 3 weeks). The response of treatment will be evaluated according to RECIST criteria. Adverse events will be documented according to CTCAE v4.03.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional chemotherapy | Active Comparator | Patients in this arm will only receive 4-8 cycles of cisplatin-based regimen. TPF ( docetaxel, cisplatin and 5-fluorouracil ), TP (docetaxel and cisplatin), GP (gemcitabine and cisplatin) and PF (cisplatin and 5-fluorouracil) regimens are preferred. |
|
| Maintenance chemotherapy 1 | Experimental | Patients in this arm will receive 6 cycles of oral fluoropyrimidine monotherapy as maintenance therapy, in addition to 4-8 cycles of cisplatin-based standard chemotherapy. |
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| Maintenance chemotherapy 2 | Experimental | Patients in this arm will receive oral fluoropyrimidine maintenance therapy until disease progression or intolerable toxicities, after 4-8 cycles of cisplatin-based standard chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional chemotherapy | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | From the time point the patients are included in the study, median of 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the time point the patients are included in the study, median of 3 years. | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | From the time point the patients are included in the study, median of 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Kong, MD | Contact | lin.kong@sphic.org.cn | ||
| Jiyi Hu, MD | Contact | jiyi.hu@sphic.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jiade J Lu, MD | Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| OTHER |
| Taichung Veterans General Hospital | OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Cancer Hospital of Guangxi Medical University | OTHER |
| National Cancer Centre, Singapore | OTHER |
| West China Hospital | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
| Tongji Hospital | OTHER |
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
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| Maintenance chemotherapy 1 |
| Drug |
|
| Maintenance chemotherapy 2 | Drug |
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| The First Affiliated Hospital of Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
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| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361003 | China |
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| Cancer Hospital of Guangxi Medical University | Recruiting | Nanning | Guangxi | 530021 | China |
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| The People's Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | Guangxi | 530021 | China |
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| Tongji Hospital, Tongji Medical College of HUST | Recruiting | Wuhan | Hubei | 430030 | China |
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| Jiangxi Province Tumor Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
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| Jiangxi Provincial Cancer Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
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| Fudan University Shanghai Cancer center | Recruiting | Shanghai | Shanghai Municipality | 201315 | China |
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| Shanghai Proton and Heavy Ion Center | Recruiting | Shanghai | Shanghai Municipality | 201315 | China |
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| Eye & ENT Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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| National Cancer Centre, Singapore | Recruiting | Singapore | 119082 | Singapore |
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| Taichung Veterans General Hospital | Recruiting | Taichung | 40705 | Taiwan |
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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 |
| 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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