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临床试验/NCT07180173
NCT07180173已完成不适用

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

Taichung Veterans General Hospital1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2007年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Progression-Free Survival (PFS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Progression-Free Survival (PFS)

时间窗: 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.

次要结局

  • Adverse Events of Salvage Treatment(From initiation of salvage therapy to 90 days post-treatment.)
  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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