MRLN-sparing Radiotherapy Trial
Description
This trial (NCT03346109) is an open-label, non-inferiority, multicentre, randomised phase III trial to compare the efficacy and safety of MRLN-sparing radiotherapy versus standard radiotherapy in patients with non-metastatic nasopharyngeal carcinoma. Primary outcome was local relapse-free survival. The 3-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 focused on 5-year survival, toxicity, and quality of life. Moreover, videofluoroscopic swallowing study and MRI measurements of pharyngeal contractors were performed for objectively-measured dysphagia This trial enrolled 568 patients from three Chinese medical centers between November 20, 2017, and December 3, 2018. With extended 5-year follow-up, MRLN-sparing radiotherapy was shown to significantly reduce observer-rated, patient-reported, and objectively-assessed dysphagia, while maintaining uncompromised efficacy. Novel objective assessments, including MRI-based measurements of pharyngeal constrictors and videofluoroscopic swallowing studies, supported by correlation analyses, demonstrated that reducing the volume and dose delivered to the superior and middle pharyngeal constrictors diminished early edema and late atrophy, translating into clinically meaningful improvements in swallowing function. These findings confirmed the long-term functional benefits of this radiotherapy de-intensification strategy and validated the principle of preserving swallowing function by sparing the MRLN region. The dataset includes ID data of patients and centers, baseline characteristics, 5 years of follow-up data, late toxicities related to radiotherapy, quality of life data, videofluoroscopic swallowing study data, MRI data of pharyngeal contractors.
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Steps to reproduce
Study detailes are available at: - Clinicaltrials.gov: NCT03346109 - Study results are available at: Wang, Shunxin, et al. "Medial Retropharyngeal Nodal Region Sparing Radiotherapy in Nasopharyngeal Carcinoma: Updated Results from an Open-label, Non inferiority, Multicentre, Randomised Phase III Trial." BMJ (2026)
Institutions
- Sun Yat-sen University Cancer CenterGuangdong, Guangzhou