Individualized Elective Neck Irradiation in NPC Patients

Individualized Elective Neck Irradiation Based on the Lymph Node Metastasis Pattern in NPC Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Radiation: Individualized Elective Neck Irradiation

Detailed 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 Type: Interventional
• Enrollment (Estimated): 470
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ling-Long Tang, Prof; Phone Number: 02087343840; Email: tangll@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Ling-Long Tang, Prof; Phone Number: 02087343840; Email: tangll@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The eligibility criteria are: newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; nodes are diagnosed with PET/CT and MRI; staged as T1-4N0-2 or N3 category of non-bilateral lower-neck node metastasis; aged between 18 and 70 years; Karnofsky performance-status score > 70; adequate haematological function, with a leucocyte count > 4 × 109/L, haemoglobin > 90 g/L, and a thrombocyte count > 100×109/L

Exclusion Criteria:

• The exclusion criteria include: previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy; lactation or pregnancy; or severe coexisting illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard group; Upper-neck irradiation at the uninvolved neck	Radiation: Individualized Elective Neck Irradiation; Individualized Elective Neck Irradiation
Experimental: Experimental group; The low-risk clinical target volume would be reduced to two vertebral levels below the vertebral level of the metastatic level II-V nodes.	Radiation: Individualized Elective Neck Irradiation; Individualized Elective Neck Irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional relapse-free survival	The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation-related toxicity	Acute and late toxicity will be documented according to RTOG/EORTC System and the CTCAE(Common Terminology Criteria for Adverse Events). Toxicity will be summarized using descriptive statistics.	Within 3 month after radiotherapy for acute toxicity; long term for late toxicity
Overall survival	The overall survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to death from any cause. Their differences will be compared between treatment arms using the log-rank test.	3 years
Local relapse-free survival	The local relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to documented local relapse or death from any cause. Their differences will be compared between treatment arms using the log-rank test.	3 years
Distant metastasis-free survival	The distant metastasis-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to documented distant metastasis or death from any cause. Their differences will be compared between treatment arms using the log-rank test.	3 years
Patient's quality-of-life: global health status	European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on global health status suggest better health.	3 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Xiangya Hospital of Central South University; Tianjin Medical University Cancer Institute and Hospital; Eye & ENT Hospital of Fudan University; Renmin Hospital of Wuhan University; First People's Hospital of Foshan; First Hospital of China Medical University; Sichuan Cancer Hospital and Research Institute; First Affiliated Hospital of Guangxi Medical University; Qingyuan People's Hospital; Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: January 28, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
• Other Study ID Numbers: B2023-651-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No