Individualized Elective Neck Irradiation in NPC Patients

Status Recruiting

Clinical Trial Summary

To evaluate whether individualized elective neck irradiation for nasopharyngeal carcinoma based on the vertebral level of metastatic lymph nodes can reduce the incidence of radiation-related adverse effects and improve patients' quality of life，without reducing survival.

Clinical Trial Description

A multicenter phase III noninferiority randomized trial (NCT02642107) showed that upper-neck irradiation at the uninvolved neck resulted in comparable regional control and survival rate to standard whole-neck irradiation in NPC, reduced late toxicity of hypothyroidism, dysphagia, and neck tissue damage, and improved quality of life, including fatigue and swallowing. However, the vertical range of the upper neck is extensive, necessitating further reduction in the scope of prophylactic irradiation. By integrating MRI and PET-CT to accurately assess metastatic lymph nodes and their corresponding vertebral levels, the investigators identified a pattern of sequential lymph node metastasis descending along the vertebral body in the vertical direction. Further correlative analysis revealed that nodal metastasis at any one of the vertebral levels strongly and positively correlated with metastasis at two adjacent vertebral levels, including one level above and one below. Considering this, the investigators propose the following scientific hypothesis: individualized elective neck irradiation for nasopharyngeal carcinoma based on the vertebral level of metastatic lymph nodes can reduce the incidence of radiation-related adverse effects and improve patients' quality of life, without reducing survival. The investigators thus conduct a multicenter randomized phase 3 trial to verify their hypothesis. ;

Study Design

Related Conditions & MeSH terms

Nasopharyngeal Carcinoma

Clinical Trial Details

NCT number	NCT06241612
Study type	Interventional
Source	Sun Yat-sen University
Contact	Ling-Long Tang, Prof
Phone	02087343840
Email	tangll@sysucc.org.cn
Status	Recruiting
Phase	Phase 3
Start date	April 16, 2024
Completion date	March 2031

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