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This is an randomized, controlled, phase 3 clinical trial. The purpose of this study is to evaluate whether medial group retropharyngeal node (MRLN) sparing could reduce the incidence of radiation-caused dysphagia and improve patients' quality of life without compromising survival rate.
In this study, patients with non-keratinizing stage T1-4 N0-3 M0 NPC(UICC/AJCC 8th edition), except for patients with MRLN metastasis, are randomly assigned to receive MRLN sparing or prophylactic irradiation . Patients in MRLN sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr. Our primary endpoint is local relapse-free survival (LRFS). Secondary end points include overall survival (OS), incidence of out-field recurrence rate, toxic effects, and quality of life (QOL).All efficacy analyses are conducted in the intention-to treat population, and the safety population include only patients who receive their randomly assigned treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRLN sparing group | Experimental | Patients in medial group retropharyngeal node(MRLN) sparing group will not routinely receive MRLN irradiation to 56Gy/33Fr |
|
| MRLN prophylactic irradiation group | No Intervention | Patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medial group retropharyngeal node(MRLN) sparing | Radiation | Patients in MRLN sparing group will not routinely receive MRLN irradiation; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr. |
| Measure | Description | Time Frame |
|---|---|---|
| Local replase-free survival rate | Local failure-free survival is calculated from randomization to the first local failure | 3 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute and late toxicity | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 year |
| Incidence of out-field recurrence rate | Number of participants with out-field recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Ma, M.D. | Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41916649 | Derived | Wang SX, Tao YL, Gao TS, Zhang N, Zhou GQ, Xie FY, Zhang Y, Guo R, Yang Y, Li YJ, Liang SQ, Zeng YC, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Liu LZ, Li HJ, Li JB, Wen HM, Sun Y, Tang LL, Liang XY, Ma J, Mao YP. Medial retropharyngeal nodal region sparing radiotherapy in nasopharyngeal carcinoma: five year analysis of open label, non-inferiority, multicentre, randomised phase 3 trial. BMJ. 2026 Mar 31;392:e086050. doi: 10.1136/bmj-2025-086050. | |
| 36746459 |
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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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| 3 Year |
| Dysphagia related quality of life | Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-HN35 | 1 year |
| Overall survival | Overall survival is calculated from randomization to death from any cause | 3 Year |
| Derived |
| Mao YP, Wang SX, Gao TS, Zhang N, Liang XY, Xie FY, Zhang Y, Zhou GQ, Guo R, Luo WJ, Li YJ, Liang SQ, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Huang SH, Liu LZ, Li JB, Tang LL, Chen L, Sun Y, Ma J. Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial. BMJ. 2023 Feb 6;380:e072133. doi: 10.1136/bmj-2022-072133. |
| 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 |