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To evaluate the efficacy and toxicity of Nimotuzumab combined with VMAT in the treatment of elderly patients with nasopharyngeal carcinoma (> 70 years old), and to provide high-level clinical evidence for the optimal treatment of elderly patients with nasopharyngeal carcinoma.
The incidence of elderly patients with nasopharyngeal carcinoma is increasing with a rapidly ageing population. However, the prognosis is worse than that of young patients. Some patients can benefit from intensive treatment such as concurrent chemoradiotherapy, but are always with obvious toxicity. With the advancement of radiotherapy technology and the emergence of molecular targeted drugs, radiotherapy combined with Nimotuzumab has shown good therapeutic efficacy and tolerance. The investigators plan to testify VMAT combined with Nimotuzumab in elderly patients with nasopharyngeal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VMAT plus Nimotuzumab | Experimental | Patients receive Nimotuzumab weekly during radiotherapy . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab 200mg/m2 IV on d1 of a week before radiotherapy , and 100mg/m2 IV on d1 weekly for 7 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate | Complete remission rate will be measured by RECIST 1.1 | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| acute treatment toxicity | Acute toxicity will be measured by CTCAE4.0 | up to 16 weeks |
| Quality of Life Assessment | EORTC,QLQ-C30 Version 3.0 are used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ye zhang, MD | Contact | 8610-87787625 | drzye1983@163.com | |
| Junlin Yi, M.D | Contact | 861087788504 | junlinyi@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Ye Zhang, professor | CAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer hospital, Chinese Academy of Medical Sciences | Recruiting | Beijin | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29155480 | Background | Cao C, Hu Q, Chen X. Intensity-modulated radiotherapy for elderly patients with nasopharyngeal carcinoma. Head Neck. 2018 Mar;40(3):590-595. doi: 10.1002/hed.25016. Epub 2017 Nov 20. | |
| 23521779 | Background | Liu H, Chen QY, Guo L, Tang LQ, Mo HY, Zhong ZL, Huang PY, Luo DH, Sun R, Guo X, Cao KJ, Hong MH, Mai HQ. Feasibility and efficacy of chemoradiotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma: results from a matched cohort analysis. Radiat Oncol. 2013 Mar 22;8:70. doi: 10.1186/1748-717X-8-70. |
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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 |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
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| VMAT | Radiation | Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx,69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume. |
|
| 2 years |
| local control rate | 2 years |
| regional control rate | 2 years |
| late treatment toxicity | late toxicity will be measured by CTCAE4.0 | 2 years |
| 24115004 | Result | Zhang Y, Yi JL, Huang XD, Xu GZ, Xiao JP, Li SY, Luo JW, Zhang SP, Wang K, Qu Y, Gao L. Inherently poor survival of elderly patients with nasopharyngeal carcinoma. Head Neck. 2015 Jun;37(6):771-6. doi: 10.1002/hed.23497. Epub 2015 Feb 11. |
| 29409313 | Result | Jin YN, Zhang WJ, Cai XY, Li MS, Lawrence WR, Wang SY, Mai DM, Du YY, Luo DH, Mo HY. The Characteristics and Survival Outcomes in Patients Aged 70 Years and Older with Nasopharyngeal Carcinoma in the Intensity-Modulated Radiotherapy Era. Cancer Res Treat. 2019 Jan;51(1):34-42. doi: 10.4143/crt.2017.551. Epub 2018 Feb 6. |
| 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 |