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| Name | Class |
|---|---|
| Fujian Province Tumor Hospital | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
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The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.
Scheme:
Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.
- Arm Cisplatin:
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT
- Arm nimotuzumab:
Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Cisplatin | Active Comparator | Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT |
|
| Arm Nimotuzumab | Experimental | Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPF neoadjuvant chemotherapy | Drug |
| ||
| Concurrent chemotherapy with cisplatin during radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities) | From Day 1 to Day 90 of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | 3 years | |
| OS | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
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| Drug |
|
| Concurrent nimotuzumab during radiotherapy | Drug |
|
| Radical radiotherapy | Radiation |
|
| 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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