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Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure

2026年8月20日 更新者：Second Affiliated Hospital, Zhejiang University, School of Medicine

Role of Postoperative Radiotherapy in T1-T2N0M0 Glottic Carcinoma Involving the Anterior Commissure: A Prospective, Multicenter, Phase II Clinical Trial

There remains no uniform treatment modality for glottic laryngeal carcinoma. Current clinical guidelines broadly recommend surgery or radiotherapy as single modality treatment for early stage glottic laryngeal carcinoma. Glottic carcinoma with anterior commissure invasion is linked to inferior local control; both definitive radiotherapy alone or transoral laser microsurgery (TLM) may confer a higher risk of local recurrence compared with other glottic carcinomas. We hypothesize that postoperative radiotherapy can act as an effective adjunct to surgery and reduce recurrence rates in patients with glottic carcinoma involving the anterior commissure. This study aims to conduct a multicenter, prospective, single arm phase II clinical trial of intensity modulated radiotherapy (IMRT) for postoperative patients with early stage glottic laryngeal carcinoma and anterior commissure involvement, to preliminarily evaluate the effect of IMRT on local control rates and long term survival outcomes in this patient population.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

38

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310009
        • 招聘中
        • Second Affiliated Hospital of Zhejiang University School of Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Aged 18 years or older, regardless of gender;
  2. Pathologically confirmed glottic squamous cell carcinoma;
  3. T1-T2N0M0 glottic laryngeal carcinoma with anterior commissure involvement;
  4. Patients who have undergone curative intent surgery for glottic carcinoma with negative surgical margins, within 4-8 weeks post operation;
  5. No prior radiotherapy, chemotherapy or other anti neoplastic agent treatment;
  6. ECOG performance status of 0 or 1;
  7. Signed informed consent form.

Exclusion Criteria:

  1. Patients without anterior commissure involvement;
  2. Prior chemotherapy or treatment with other anti neoplastic agents;
  3. Prior history of head and neck radiotherapy;
  4. Prior participation in other clinical trials;
  5. Patients with severe allergy history or allergic diathesis, e.g., contrast medium allergy;
  6. Pregnant or lactating women;
  7. Patients with uncontrolled acute infection;
  8. Patients with drug addiction, substance abuse, chronic heavy alcohol consumption, or human immunodeficiency virus (HIV) infection;
  9. Patients with other uncontrolled concurrent malignancies.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Postoperative radiotherapy
intensity modulated radiotherapy (IMRT)
辐射：intensity modulated radiotherapy (IMRT)

Postoperative radiotherapy clinical target volume (CTV) design: The conventional postoperative laryngeal radiotherapy target is defined as CTV1, which encompasses the entire laryngeal structure, piriform sinus, gloss-epiglottic vallecula, paraglottic space, pre-epiglottic space, thyroid cartilage, and extends to the inferior border of the cricoid cartilage. For T2 tumours, CTV2 is delineated to include bilateral cervical lymph node regions II-III.

PTV1 and PTV2 are defined as the regions expanded by 3 mm outward from CTV1 and CTV2, respectively. The prescribed dose for PTV1 is 60 Gy in 30 fractions (60 Gy/30F), and the prescribed dose for PTV2 is 54 Gy in 30 fractions (54 Gy/30F).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
3-year local-regional failure-free survival (LRFS)
大体时间：From the date of surgery to the date of local recurrence, , assessed up to 3 year.
3-year local-regional failure-free survival (LRFS): defined as the time from the date of surgery to recurrence of the primary lesion and perilesional tissues. The index date for recurrence is the date when a measurable new lesion is first identified. For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of surgery to the date of death. For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
From the date of surgery to the date of local recurrence, , assessed up to 3 year.

次要结果测量

结果测量
措施说明
大体时间
Adverse events
大体时间：From enrollment to the end of treatment at 5 years.
The incidence, type, and severity of adverse events (AEs), serious AEs, and immune-related AEs (irAEs) were assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0).
From enrollment to the end of treatment at 5 years.
5-year local-regional failure-free survival (LRFS)
大体时间：From the date of surgery to the date of local recurrence, assessed up to 5 year.
5-year local-regional failure-free survival (LRFS): defined as the time from the date of surgery to recurrence of the primary lesion and perilesional tissues. The index date for recurrence is the date when a measurable new lesion is first identified. For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of surgery to the date of death. For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
From the date of surgery to the date of local recurrence, assessed up to 5 year.
5-year overall survival (OS)
大体时间：From the date of surgery until the date of surgery due to any cause, assessed up to 5 year.
Overall Survival(OS) is defined as the period from the date of surgery to the date of death due to any cause.
From the date of surgery until the date of surgery due to any cause, assessed up to 5 year.
5-year disease-free survival (DFS)
大体时间：Time from the date of surgery to any evidence of tumour growth or death, assessed up to 5 year.
5-year disease-free survival (DFS): defined as the time from the date of surgery during which the patient remains alive without evidence of tumour growth. Recurrence is defined as the emergence of new lesions, including recurrence of the primary lesion and perilesional tissues, cervical lymph-node metastasis, and distant metastasis. The index date for recurrence is the date on which a measurable new lesion is first identified. For patients who die of any other cause prior to documented disease recurrence, DFS is calculated from the date of surgery to the date of death. For patients with no documented disease recurrence or death at the time of analysis (i.e., disease-free survivors), the time of the last efficacy assessment will serve as the endpoint.
Time from the date of surgery to any evidence of tumour growth or death, assessed up to 5 year.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Second Affiliated Hospital, Zhejiang University, School of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月16日

初级完成 (估计的)

2031年12月31日

研究完成 (估计的)

2031年12月31日

研究注册日期

首次提交

2026年8月18日

首先提交符合 QC 标准的

2026年8月20日

首次发布 (实际的)

2026年8月24日

研究记录更新

最后更新发布 (实际的)

2026年8月24日

上次提交的符合 QC 标准的更新

2026年8月20日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2026-0861

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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