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To Study the Feasibility and Quality of Life of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03346109
Study type Interventional
Source Sun Yat-sen University
Contact
Status Active, not recruiting
Phase N/A
Start date November 16, 2017
Completion date December 30, 2022
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