Trial reportBMJ (Clinical research ed.)2026
Medial retropharyngeal nodal region sparing radiotherapy in nasopharyngeal carcinoma: five year analysis of open label, non-inferiority, multicentre, randomised phase 3 trial.
Trial report in BMJ (Clinical research ed.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03346109 (Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Prospective Randomised Controlled Non-inferior Trial Studying the Feasibility and Potential Quality of Life Benefits of Medial Group Retropharyngeal Node Sparing in Nasopharyngeal Carcinoma
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27 authors.
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Abstract
objectiveTo determine the pre-specified long term efficacy (survival and swallowing function) and safety of medial retropharyngeal lymph node (MRLN) region sparing radiotherapy for non-metastatic nasopharyngeal carcinoma.
designPre-specified five year analysis of an open label, non-inferiority, multicentre, randomised phase 3 trial.
settingThree Chinese medical centres between 20 November 2017 and 3 December 2018.
participantsAdults (18-65 years) with untreated, non-keratinising, non-metastatic nasopharyngeal carcinoma without MRLN involvement.
interventionsEligible patients were randomised (1:1; block size of four) to MRLN sparing radiotherapy or standard radiotherapy. Randomisation was stratified by institution and treatment modality (radiotherapy alone, concurrent chemoradiotherapy, or induction chemotherapy plus radiotherapy or concurrent chemoradiotherapy).
main outcome measuresThe primary outcome was local relapse-free survival. The three year local relapse-free survival to assess the non-inferiority, with a margin of 8%, of MRLN sparing radiotherapy compared with standard radiotherapy has been reported previously. This updated report focuses on five year survival, toxicity, and quality of life. Additionally, a videofluoroscopic swallowing study and magnetic resonance imaging (MRI) measurements of pharyngeal contractors were used as objective measures of dysphagia
resultsThis trial enrolled 285 patients in the MRLN sparing group and 283 patients in the standard group. At a median follow-up of 70 months, the MRLN sparing and standard groups had similar five year local relapse-free survival (89.2% (95% confidence interval (CI) 85% to 92%) versus 90.6% (87% to 94%); stratified hazard ratio 1.03 (95% CI 0.61 to 1.74); P=0.90) and overall survival (89.2% (85% to 93%) versus 90.3% (87% to 94%); stratified hazard ratio 1.06 (0.68 to 1.68); P=0.79). Updated safety profiles of the MRLN sparing group showed a lower rate of grade ≥1 dysphagia (45/206 (22%)
conclusionsMRLN sparing radiotherapy maintained uncompromised efficacy and better long term swallowing function by reducing radiation damage to pharyngeal contractors, supporting its use as a standard of care for non-metastatic nasopharyngeal carcinoma.
trial registrationClinicalTrials.gov NCT03346109.
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