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| Name | Class |
|---|---|
| Jiangxi Provincial Cancer Hospital | OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Chongqing University Cancer Hospital | OTHER |
| Dongguan People's Hospital |
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This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced CTVn2 | Experimental | Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level. |
|
| Conventional CTVn2 | Active Comparator | Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity Modulated Radiation Therapy | Radiation | All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225). |
| Measure | Description | Time Frame |
|---|---|---|
| Regional recurrence-free survival | From the date of randomization to regional recurrence or any death | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up | 3 years |
| Local recurrence-free survival | From the date of randomization to local recurrence or any death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chong Zhao, MD PhD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | China | |||
| Dongguan People Hospital |
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| Label | URL |
|---|---|
| Home Page of Cancer Center, Sun Yat-sen University | View source |
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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 |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| OTHER_GOV |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Liuzhou Workers' Hospital | OTHER_GOV |
| The First Affiliated Hospital of Xiamen University | OTHER |
| Wuzhou Red Cross Hospital | OTHER |
| Hubei Cancer Hospital | OTHER |
| First Hospital of China Medical University | OTHER |
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|
| Chemotherapy | Drug | Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition. |
|
| 3 years |
| Distant metastasis-free survival | From the date of randomization to distant metastasis or any death | 3 years |
| Progression free survival | From the date of randomization to local or regional recurrence, distant metastasis or any death | 3 years |
| Acute toxicities | Assessed with CTCAE v5.0 | From the start of treatment until 3 months post treatment |
| Late toxicities | Assessed with RTOG/EORTC | 3 years post treatment |
| Quality of life score | Assessed with EORTC-Quality of life questionnaire-C30 version 3.0 | During treatment and 3 years post treatment |
| Dongguan |
| Guangdong |
| China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Liuzhou Worker's Hospital | Liuzhou | Guangxi | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | China |
| Jiangxi Cancer Hospital of Nanchang University | Nanchang | Jiangxi | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 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 |