NCT07180173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
17.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

17.2 years

First QC Date

September 11, 2025

Last Update Submit

March 19, 2026

Conditions

Keywords

PrognosisTreatment failureNasopharyngeal carcinomaIntensity-modulated radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    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.

    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.

Secondary Outcomes (4)

  • Overall Survival (OS)

    From treatment completion to death from any cause, up to 5 years.

  • Locoregional Recurrence-Free Survival (LRRFS)

    From treatment completion to the first occurrence of locoregional recurrence, up to 5 years.

  • Patterns of Failure

    From treatment completion to recurrence/metastasis, up to 5 years.

  • Adverse Events of Salvage Treatment

    From initiation of salvage therapy to 90 days post-treatment.

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes adult patients aged 18 years or older with pathologically confirmed nasopharyngeal carcinoma (NPC), staged as Stage IV (Tany N3) according to the 8th edition of the AJCC staging system. All participants have completed definitive concurrent chemoradiotherapy (CCRT) or induction chemotherapy (IC) followed by radiotherapy/CCRT, and have complete clinical imaging and medical records before and after treatment for subsequent efficacy and prognostic analysis. This cohort represents high-risk patients with advanced nodal disease, characterized by increased risks of both locoregional recurrence and distant metastasis, making them suitable for evaluating current treatment outcomes and subsequent management strategies.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Related Publications (2)

  • Chiang CL, Guo Q, Ng WT, Lin S, Ma TSW, Xu Z, Xiao Y, Li J, Lu T, Choi HCW, Chen W, Chau ESC, Luk PHY, Huang SH, O'Sullivan B, Pan J, Lee AWM. Prognostic Factors for Overall Survival in Nasopharyngeal Cancer and Implication for TNM Staging by UICC: A Systematic Review of the Literature. Front Oncol. 2021 Sep 2;11:703995. doi: 10.3389/fonc.2021.703995. eCollection 2021.

  • Huang CL, Guo R, Li JY, Xu C, Mao YP, Tian L, Lin AH, Sun Y, Ma J, Tang LL. Nasopharyngeal carcinoma treated with intensity-modulated radiotherapy: clinical outcomes and patterns of failure among subsets of 8th AJCC stage IVa. Eur Radiol. 2020 Feb;30(2):816-822. doi: 10.1007/s00330-019-06500-5. Epub 2019 Oct 24.

MeSH Terms

Conditions

NeoplasmsNasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 18, 2025

Study Start

April 1, 2007

Primary Completion

May 31, 2024

Study Completion

December 15, 2025

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations