Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma

Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma: A Phase III Randomized Non-Inferiority Trial

This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study will evaluate whether omitting Level Va irradiation in patients without these risk features does not compromise regional control or survival, with the goal of providing robust evidence to guide further personalization of NPC radiotherapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasopharyngeal Carcinoma by AJCC V9 Stage
• Intervention / Treatment: Radiation: Omission of Level Va Irradiation in Nasopharyngeal Carcinoma

• Study Type: Interventional
• Enrollment (Estimated): 474
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qiaojuan Guo; Phone Number: 15080013157; Email: guoqiaojuan163@.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 351100
      • Fujian Cancer Hospital
      • Contact: Qiaojuan Guo, DR

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
2. No distant metastatic;
3. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
4. Signing informed consent;
5. Follow up regularly and comply with test requirements.

Exclusion Criteria:

1. Ipsilateral Level IIb involvement;
2. Ipsilateral Level III nodes involvement;
3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c);
4. Disease progression during IMRT;
5. Previous malignancy or other concomitant malignant diseases;
6. The evaluation information of tumor efficacy can not be obtained;
7. Receive blind treatment in other clinical research;
8. Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
9. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
10. Active systemic infection;
11. No or limited capacity for civil conduct;
12. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
13. Pregnancy or lactation period;

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
Experimental: level Va-sparing IMRT; Level Va irradiation is omitted except in the presence of any of the following high-risk features: Ipsilateral Level IIb involvement;; Ipsilateral Level III nodes involvement;; Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c);	Radiation: Omission of Level Va Irradiation in Nasopharyngeal Carcinoma; Level Va should be irradiated only in the presence of any of the following high-risk features: 1. Ipsilateral Level IIb involvement; 2. Ipsilateral Level III nodes involvement; 3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c).
No Intervention: level Va-covering IMRT; Level Va is routinely irradiated according to CACA/CMDA guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional failure-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
overall survival	time from the date of the start of chemotherapy to death due to any cause	3 years
Distant metastasis-free survival	The distant metastasis-free survival rate will be estimated using Kaplan-Meier	3 years
Local failure-free survival	until documented treatment local failure or death from any cause.	3 years
Patient's quality-of-life	European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck Questionnaire	3 years

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital
• Investigators: Study Chair: Qiaojuan Guo, Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NPC013

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