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The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT) alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally advanced nasopharyngeal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT alone | Experimental | SIB-IMRT was given to the patients with a regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume |
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| CCRT group | Active Comparator | SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume and cisplatin 100mg/m2 was given at d1, d22,d43 during radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIB-IMRT | Radiation | SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | according to the recruitment, a interrim analysis will done in July, 2019, if there is inferior finding of RT alone group, the study will premature terminate | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and late toxicities |
| 5years |
| 3 year Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junlin YI, MD | Contact | 861087788504 | yijunlin1969@163.com | |
| Kai Wang, MD | Contact | 8613910741366 | kaiwang2007@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Gao, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
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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 |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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central investigator organization digital randomize
| Cisplatin | Drug | Cisplatin 100mg/m2 was delivered at d1,d22 and d43 to the CCRT group patients during radiotherapy. |
|
to compare the 3years PFS between the IMRT alone and IMRT with concurrent chemoradiotherapy
| 5year |
| Department of Radiation oncology, Cancer hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430030 | China |
|
| Tongji hospital, Huazhong University of Science & Technology | Recruiting | Wuhan | Hubei | 430032 | China |
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| Jiangxi province cancer hospital | Not yet recruiting | Nanchang | Jiangxi | 330029 | China |
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| Cancer hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | 100021 | China |
|
| 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 |