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| Name | Class |
|---|---|
| First People's Hospital of Foshan | OTHER |
| Affiliated Hospital of Guangdong Medical University | OTHER |
| The Wuzhou Red Cross Hospital | UNKNOWN |
| Fourth Affiliated Hospital of Guangxi Medical University |
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This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture.
This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture. The enrolled patients will be 1:1 randomly assigned to receive reduced CTV delineation radiotherapy (anterior border of CTV2 defined as 5 mm anterior to the choanae), or standard CTV delineation radiotherapy (anterior border of CTV2 defined as the posterior 1/3 of the nasal cavity).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced delineation arm | Experimental |
| |
| Standard delineation arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard CTV delineation | Radiation | The anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local relapse-free survival | The time from randomization to documented local relapse or death from any cause. | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The time from randomization to death from any cause or censored at the date of the last follow-up. | 3 year |
| Progression-free survival | The time from randomization to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occur first. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of olfactory dysfunction | Olfactory function was assessed using the Visual Analogue Scale (VAS) before radiotherapy, at the end of radiotherapy, and at 3, 6, 12 month after radiotherapy. | 1 year |
| Incidence of acquired nasal cavity stenosis and atresia |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hai-Qiang Mai, Dr. | Contact | +8602087343380 | maihq@sysucc.org.cn | |
| Qiu-Yan Chen, Dr. | Contact | +8602087343380 | chenqy@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First People's Hospital of Foshan | Foshan | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36746459 | Background | 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. | |
| 30712708 |
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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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| OTHER |
| Zhongshan City People 's Hospital | UNKNOWN |
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| reduced CTV delineation | Radiation | The anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae. |
|
| 3 year |
| Distant metastasis-free survival | The time from randomization to distant metastasis or death from any cause. | 3 year |
| Regional relapse-free survival | The time from randomization to documented regional relapse or death from any cause. | 3 year |
| Incidence rate of adverse events (AEs) | Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. | 2 year |
| Change of quality of life | Quality of life scores were assessed for each scale by using the 22-item Sino-Nasal Outcome Test (SNOT-22) before radiotherapy, at the end of radiotherapy, and at the 3, 6, 12 month after radiotherapy. | 1 year |
Acquired nasal cavity stenosis and atresia was assessed by electronic nasopharyngoscopy before radiotherapy, at the end of radiotherapy, and at 3, 6, and 12 months after radiotherapy. |
| 1 year |
| Incidence of radiation-induced sinusitis | Radiation-induced sinusitis was assessed by head and neck enhanced magnetic resonance imaging (MRI) before radiotherapy, at the end of radiotherapy, and at 3, 6, and 12 months after radiotherapy. | 1 year |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China |
|
| Affiliated Hospital of Guangdong Medical University | Zhangjiang | Guangdong | China |
|
| The Fourth Affiliated Hospital of Guangxi Medical University | Liuzhou | Guangxi | China |
|
| Wuzhou Red Cross Hospital | Wuzhou | Guangxi | China |
|
| Background |
| Sanford NN, Lau J, Lam MB, Juliano AF, Adams JA, Goldberg SI, Lu HM, Lu YC, Liebsch NJ, Curtin HD, Chan AW. Individualization of Clinical Target Volume Delineation Based on Stepwise Spread of Nasopharyngeal Carcinoma: Outcome of More Than a Decade of Clinical Experience. Int J Radiat Oncol Biol Phys. 2019 Mar 1;103(3):654-668. doi: 10.1016/j.ijrobp.2018.10.006. Epub 2018 Oct 15. |
| 40419028 | Background | Lin SJ, Guo QJ, Liu Q, Ng WT, Ahn YC, AlHussain H, Chan AW, Chow J, Chua MLK, Corry J, Han F, Gregoire V, Harrington KJ, Hu CS, Jensen K, Langendijk JA, Le QT, Lee NY, Lee V, Lin JC, Ma J, Mendenhall WM, O'Sullivan B, Ozyar E, Rosenthal DI, Tao YG, Wang RS, Wee J, Xu ZY, Yi JL, Yom SS, Fan DM, Mai HQ, Pan JJ, Lee AWM. International Consensus Guideline on Delineation of the Clinical Target Volumes at Different Dose Levels for Nasopharyngeal Carcinoma (2024 Version). Int J Radiat Oncol Biol Phys. 2025 Oct 1;123(2):415-431. doi: 10.1016/j.ijrobp.2025.05.019. Epub 2025 May 24. |
| 22178121 | Background | Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15. |
| 19251378 | Background | Liang SB, Sun Y, Liu LZ, Chen Y, Chen L, Mao YP, Tang LL, Tian L, Lin AH, Liu MZ, Li L, Ma J. Extension of local disease in nasopharyngeal carcinoma detected by magnetic resonance imaging: improvement of clinical target volume delineation. Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):742-50. doi: 10.1016/j.ijrobp.2008.11.053. Epub 2009 Feb 27. |
| 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 |