Upfront Neck Dissection Before Radiotherapy in Stage N3 Nasopharyngeal Carcinoma: A Retrospective Study

Active, not recruiting

• Conditions: Oncology; Radiology

• Registration Number: NCT07180173
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

This retrospective observational study aims to evaluate the association between neck tumor burden and high-risk imaging features with locoregional recurrence and distant metastasis in patients with stage N3 nasopharyngeal carcinoma, and to explore the potential benefits of neck dissection, with or without re-irradiation or systemic therapy, in improving regional control and survival.

The key questions addressed are whether high N burden and high-risk imaging features are significantly correlated with neck recurrence and distant metastasis, and whether salvage neck treatment (such as neck dissection ± re-irradiation/systemic therapy) can improve regional control and survival outcomes in this high-risk population.

Detailed Description

Nasopharyngeal carcinoma (NPC), due to its anatomical proximity to the skull base and critical cervical structures, is primarily treated with radiotherapy. However, even with current standard treatments, a subset of patients still develop locoregional failure with poor outcomes. Previous data have shown that the 5-year locoregional control rate for stage IV disease is approximately 80.7%, corresponding to a failure rate of about 20%. Among these, patients with T1-4N3 disease have a lower 3-year distant failure-free survival compared with T4N0-2, indicating that high N stage is associated not only with regional recurrence but also with increased risk of distant metastasis. Based on this, we hypothesize that high nodal burden and high-risk imaging features are significantly associated with cervical recurrence and distant metastasis, and that appropriate and timely salvage treatment to the neck (such as neck dissection with or without re-irradiation/systemic therapy) may improve regional control and survival.

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2025-08-20
• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Study Completion: 2026-09-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Age ≥ 18 years.
• Pathologically confirmed diagnosis of nasopharyngeal carcinoma (NPC).
• Stage IV disease (Tany N3) according to the 8th edition of the AJCC staging system.
• Completion of definitive concurrent chemoradiotherapy (CCRT), or induction chemotherapy (IC) followed by radiotherapy/CCRT.
• Availability of complete clinical imaging and medical records before and after treatment for efficacy and prognostic analysis.

Exclusion Criteria

• Presence of distant metastasis at initial diagnosis.
• Prior history of treatment for other head and neck malignancies, aside from definitive therapy for NPC (to avoid confounding prognosis).
• Incomplete or prematurely discontinued definitive radiotherapy, resulting in failure to complete the planned curative treatment.
• Lack of complete pathology report, clinical imaging, or treatment records, making effective analysis impossible.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	From completion of primary treatment (CCRT or induction chemotherapy plus RT/CCRT) to disease progression, recurrence, or death from any cause, up to 5 years.	PFS is defined as the time from treatment completion to the first documented disease progression (locoregional recurrence or distant metastasis) or death, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Adverse Events of Salvage Treatment	From initiation of salvage therapy to 90 days post-treatment.	Acute and late adverse events related to salvage neck dissection, re-irradiation, or systemic therapy, graded according to CTCAE v5.0.
Overall Survival (OS)	From treatment completion to death from any cause, up to 5 years.	OS is defined as the duration from treatment completion until death from any cause.
Locoregional Recurrence-Free Survival (LRRFS)	From treatment completion to the first occurrence of locoregional recurrence, up to 5 years.	LRRFS is defined as the time from treatment completion to the first documented local or regional recurrence.
Patterns of Failure	From treatment completion to recurrence/metastasis, up to 5 years.	Documenting the site and timing of failure (local, regional, distant) based on imaging and pathology reports.

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan