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This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study will evaluate whether omitting Level Va irradiation in patients without these risk features does not compromise regional control or survival, with the goal of providing robust evidence to guide further personalization of NPC radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| level Va-sparing IMRT | Experimental | Level Va irradiation is omitted except in the presence of any of the following high-risk features:
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| level Va-covering IMRT | No Intervention | Level Va is routinely irradiated according to CACA/CMDA guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omission of Level Va Irradiation in Nasopharyngeal Carcinoma | Radiation | Level Va should be irradiated only in the presence of any of the following high-risk features: 1. Ipsilateral Level IIb involvement; 2. Ipsilateral Level III nodes involvement; 3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c). |
| Measure | Description | Time Frame |
|---|---|---|
| Regional failure-free survival | The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | time from the date of the start of chemotherapy to death due to any cause | 3 years |
| Distant metastasis-free survival | The distant metastasis-free survival rate will be estimated using Kaplan-Meier |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiaojuan Guo | Contact | 15080013157 | guoqiaojuan163@.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiaojuan Guo | Fujian Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer hospital | Fuzhou | Fujian | 351100 | China |
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| 3 years |
| Local failure-free survival | until documented treatment local failure or death from any cause. | 3 years |
| Patient's quality-of-life | European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck Questionnaire | 3 years |