OncologyNCT07180173
Upfront Neck Dissection Before Radiotherapy in Stage N3 Nasopharyngeal Carcinoma: A Retrospective Study
An observational study of Oncology and Radiology, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Salvage Neck Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2007to 15 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Upfront Neck Dissection Before Radiotherapy in Stage N3 Nasopharyngeal Carcinoma
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.
Read the 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.
- Being tested
- Salvage Neck Treatment
- Keywords
- Prognosis, Treatment failure, Nasopharyngeal carcinoma, Intensity-modulated radiotherapy
- Medical subject headings
- Neoplasms, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvage Neck TreatmentRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
OS is defined as the duration from treatment completion until death from any cause.
Measured: From treatment completion to death from any cause, up to 5 years.
Locoregional Recurrence-Free Survival (LRRFS)
LRRFS is defined as the time from treatment completion to the first documented local or regional recurrence.
Measured: From treatment completion to the first occurrence of locoregional recurrence, up to 5 years.
Patterns of Failure
Documenting the site and timing of failure (local, regional, distant) based on imaging and pathology reports.
Measured: From treatment completion to recurrence/metastasis, up to 5 years.
Adverse Events of Salvage Treatment
Acute and late adverse events related to salvage neck dissection, re-irradiation, or systemic therapy, graded according to CTCAE v5.0.
Measured: From initiation of salvage therapy to 90 days post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Apr 2007
- Primary completion31 May 2024
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180173
- Sponsor's protocol ID
- CE25786B
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34540670Huang 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.
PubMed 31650266
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Upfront Neck Dissection Before Radiotherapy in Stage N3 Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07180173
- Acronym / sponsor ID
- CE25786B
- Keywords
- Prognosis, Treatment failure, Nasopharyngeal carcinoma, Intensity-modulated radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2007 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salvage Neck TreatmentSalvage 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. | Radiation | – |
Primary outcome
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.
4 secondary outcomes
Overall Survival (OS)
Time frame: From treatment completion to death from any cause, up to 5 years.
Locoregional Recurrence-Free Survival (LRRFS)
Time frame: From treatment completion to the first occurrence of locoregional recurrence, up to 5 years.
Patterns of Failure
Time frame: From treatment completion to recurrence/metastasis, up to 5 years.
Adverse Events of Salvage Treatment
Time frame: From initiation of salvage therapy to 90 days post-treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 34540670Chiang 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.
- Results publication: PubMed 31650266Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Radiology, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180173, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.