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.
Newly diagnosed, histologically confirmed non-keratinizing carcinoma (WHO classification).
Stage I-III disease (AJCC 9th edition).
Tumor extends to nasal cavity (including nasal septum).
No distant metastasis (M0).
Keratinizing squamous cell carcinoma (WHO Type I) or basaloid squamous cell carcinoma.
Age <18 or >70 years.
Recurrent disease or distant metastasis.
No tumor extension into the nasal cavity (including the nasal septum).
Parallel
standard CTV delineation
RadiationThe anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity.
reduced CTV delineation
RadiationThe anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae.
Local relapse-free survival
The time from randomization to documented local relapse or death from any cause.
Overall survival
The time from randomization to death from any cause or censored at the date of the last follow-up.
Progression-free survival
The time from randomization to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occur first.
Distant metastasis-free survival
The time from randomization to distant metastasis or death from any cause.
Regional relapse-free survival
The time from randomization to documented regional relapse or death from any cause.
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.
Incidence of acquired nasal cavity stenosis and atresia
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.
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.
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Hai-Qiang Mai,MD,PhD
Lead sponsor
Sun Yat-sen University
Sponsor institution
First People's Hospital of Foshan
Collaborator
Affiliated Hospital of Guangdong Medical University
Collaborator
The Wuzhou Red Cross Hospital
Collaborator
The Fourth Affiliated Hospital of Guangxi Medical University
Collaborator
Zhongshan City People 's Hospital
Collaborator
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