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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
568
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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Local replase-free survival rate
Local failure-free survival is calculated from randomization to the first local failure
Time frame: 3 Year
Incidence of acute and late toxicity
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
Incidence of out-field recurrence rate
Number of participants with out-field recurrence
Time frame: 3 Year
Dysphagia related quality of life
Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-HN35
Time frame: 1 year
Overall survival
Overall survival is calculated from randomization to death from any cause
Time frame: 3 Year
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