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NCT Number: NCT07180173

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salvage Neck Treatment

Radiation

Salvage neck treatment, including neck dissection with or without re-irradiation and/or systemic therapy, administered to patients with stage N3 nasopharyngeal carcinoma after completion of definitive concurrent chemoradiotherapy (CCRT) or induction chemotherapy followed by radiotherapy/CCRT.

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 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 outcomes

  1. Overall Survival (OS)

    Time frame: 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.

  2. Locoregional Recurrence-Free Survival (LRRFS)

    Time frame: 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.

  3. Patterns of Failure

    Time frame: 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.

  4. Adverse Events of Salvage Treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

Retrospective Analysis of Upfront Neck Dissection Before Radiotherapy in Stage N3 Nasopharyngeal Carcinoma

Important dates

Study start
2007
Primary completion
2024
Study completion
2025
First posted
Sep 18, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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