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| Name | Class |
|---|---|
| Liuzhou Workers' Hospital | OTHER_GOV |
| Wuzhou Red Cross Hospital | OTHER |
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Nasopharyngeal carcinoma (NPC) is commonly observed in southern China, particularly in the Pearl River delta area and the Xijiang River basin in the Guangdong and Guangxi provinces, with an incidence rate as high as 25-50 per 100,000. The National Comprehensive Cancer Network guidelines (version 1, 2018), have recommended use of induction chemotherapy followed by CCRT as category 2A for NPC, especially the TPF regimen as category 1 for EBV-associated disease. The nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a promising new agent with more efficient entry to the tumor microenvironment and preferential uptake by cancer cells. Superior activity of Nab-paclitaxel regimens without the necessity for antianaphylactic pretreatments has been shown in various solid tumors compared with the traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of combination of Nab-paclitaxel, cisplatin and Fluorouracil (APF) has not been determined in patients with locoregionally advanced NPC. In this prospective, Multi-centeric, Open, Non-controlled phase II clinical trial, investigators perform an exploratory study to the efficacy and Safety of APF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction chemotherapy and concurrent chemoradiotherapy | Experimental | Patients receive induction chemotherapy with Nab-paclitaxel, cisplatin and fluorouracil every three weeks for three cycles before radiotherapy, and then receive concurrent chemoradiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel, Cisplatin and Fluorouracil | Drug | Patients receive Nab-paclitaxel (200mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before concurrent chemoradiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | To be determined by measurement of target lesions according to RECIST criteria | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival (FFS) | From the date of registration to the date of either locally, regionally or distant failure or last follow-up | 3 years |
| Overall survival(OS) | From the date of registration to the date of death is observed or to last follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
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|
| concurrent chemoradiotherapy | Radiation | Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. |
|
|
| 3 years |
| Adverse Events | Incidence of Treatment-Emergent Adverse Events Evaluated according to NCI-CTC AE V4.03 | 3 years |
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | 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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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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