Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma

NCT ID: NCT07268690

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 474 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2030-12-31

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma by AJCC V9 Stage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

level Va-sparing IMRT

Level Va irradiation is omitted except 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);

Group Type: EXPERIMENTAL

Omission of Level Va Irradiation in Nasopharyngeal Carcinoma

Intervention Type: RADIATION

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).

level Va-covering IMRT

Level Va is routinely irradiated according to CACA/CMDA guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: RADIATION

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiaojuan Guo

Role: STUDY_CHAIR

Fujian Cancer Hospital

Locations

Fujian Cancer hospital

Fuzhou, Fujian, China

Countries

China

Central Contacts

Qiaojuan Guo

Role: CONTACT

guoqiaojuan163@.com

15080013157

Facility Contacts

Qiaojuan Guo, DR

Role: primary

Other Identifiers

NPC013

Identifier Type: -

Identifier Source: org_study_id