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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
550
The anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity.
The anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae.
First People's Hospital of Foshan
Foshan, Guangdong, China
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
Liuchow, Guangxi, China
Local relapse-free survival
The time from randomization to documented local relapse or death from any cause.
Time frame: 3 year
Overall survival
The time from randomization to death from any cause or censored at the date of the last follow-up.
Time frame: 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.
Time frame: 3 year
Distant metastasis-free survival
The time from randomization to distant metastasis or death from any cause.
Time frame: 3 year
Regional relapse-free survival
The time from randomization to documented regional relapse or death from any cause.
Time frame: 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.
Time frame: 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.
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Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Time frame: 1 year