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| Name | Class |
|---|---|
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
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This is a Phase III trial to study the effectiveness of nimotuzumab versus cisplatin combined with intensity-modulated radiation therapy (IMRT) in treating patients with stage II-III nasopharyngeal carcinoma.
Scheme:
Eligible stage II and III NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.
- Arm Cisplatin: cisplatin 40mg/m2/week in concurrent with IMRT
- Arm nimotuzumab: nimotuzumab 200mg/week in concurrent with IMRT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab | Experimental | nimotuzumab 200mg/week in concurrent with IMRT |
|
| Cisplatin | Active Comparator | cisplatin 40mg/m2/week in concurrent with IMRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival (PFS) | Progress-free survival is calculated from the date of randomization to the date of the first progress at any site. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up. | 2 years |
| Locoregional Relapse-Free Survival (LRRFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yuan Chen, MD,PhD | Contact | +86-20-87343361 | chenmy@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming-Yuan Chen, MD,PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D009303 | Nasopharyngeal Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT |
|
The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
| 2 years |
| Distant Metastasis-Free Survival (DMFS) | The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit. | 2 years |
| Number of participants with adverse events | up to 2 years |
| D010610 |
| Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009371 | Neoplasms by Site |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |