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Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced SNMM (SNMM)

2021年8月16日 更新者：Hongmeng Yu、Eye & ENT Hospital of Fudan University

A Prospective Single Arm Clinical Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced Sinonasal Malignant Melanoma

Sinonasal mucosal melanoma (SNMM) is a very rare tumor, and SNMM is highly aggressive in nature, with a 5-year survival rate of about 20~30%. Most patients underwent local recurrence and distant metastasis within one or two years of treatment.

There is no unified standard for the treatment of SNMM.The principle of treatment for surgically resectable stage T3 and partial T4 SNMM is complete resection of the primary tumor, combined with postoperative radiotherapy. While locally unresectable SNMM has a poorer prognosis, lower incidence, fewer clinical data have been reported.

This study will explore the role of preoperative radiotherapy and chemotherapy in improving the 2-year OS rate, loco-regional control rate and distant metastasis rate.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (预期的)

28

阶段

  • 第一阶段早期

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

  • 姓名：Xiaole Song, MD
  • 电话号码：15821388769
  • 邮箱：jxfxsxl@163.com

学习地点

  • 中国
    • Shanghai
      • Shanghai、Shanghai、中国、200031
        • 招聘中
        • Eye& ENT Hospital, Fudan University
        • 接触：
          • Weifang Wang
          • 电话号码：13916229507
        • 副研究员：
          • Xiaoshen Wang, MD,PhD

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age over 18 years old;
  2. Pathologically confirmed with sinonasal mucosal melanoma;
  3. Eligible for assessment by enhanced contrast computed tomography scan or magnetic Resonance Imaging (MRI);
  4. T4N0-1M0 according to the 8th edition American Joint Committee on Cancer (AJCC) staging system, and breaks through the natural anatomical boundaries of orbital fascia or dura mater; or 2) any Tumor stage, with retropharyngeal node metastasis. unresectable tumor after multi-disciplinary team (MDT) discussion.
  5. Eastern Cooperative Oncology Group (ECOG) score between 0 to 2;
  6. No distant metastasis;
  7. Adequate organ function;
  8. Sign the informed consent forms.

Exclusion Criteria:

  1. There is evidence or suspicious of distant metastasis on clinical examination or imaging examination;
  2. suffered from uncontrolled concurrent diseases that may interfere with treatment;
  3. Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.);
  4. With surgical contraindications: severe cardiopulmonary disease, coagulation dysfunction, etc;
  5. With and conditions that interfere with patient compliance or safety;
  6. With severe mental or neurological diseases;
  7. Uncontrolled active infection diseases;
  8. Pregnant or breastfeeding women;
  9. Patients without personal freedom or independent civil capacity;
  10. Other situations that are not suitable.

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：Preoperative radiotherapy and chemotherapy
Preoperative radiotherapy and chemotherapy plus endoscopic surgery
程序：endoscopic surgery
endoscopic surgery or endoscope-assisted surgery open surgery
辐射：intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy
radiotherapy was administrated before surgery
药品：Chemotherapy drug
Chemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases.

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
Overall survival
大体时间：From date of first treatment until the date of death from any cause,through study completion,up to 2 years.
2 year Overall Survival rate
From date of first treatment until the date of death from any cause,through study completion,up to 2 years.

次要结果测量

结果测量
措施说明
大体时间
Progression-free survival
大体时间：From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to2 years
the date of first treatment to the first recording of disease progression or death from any cause.
From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to2 years
Local progression free survival
大体时间：From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years
the date of first treatment to local failure or death
From date of first treatment to local failure or date of death from any cause,through study completion,up to 2 years
Regional progression free survival
大体时间：From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years
the date of first treatment to regional failure or death
From date of first treatment to regional failure or date of death from any cause, through study completion,up to 2 years
Distant metastasis free survival
大体时间：From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years
the date of first treatment to distant metastasis or death
From date of first treatment to distant metastasis or date of death from any cause, through study completion,up to 2 years
ORR
大体时间：From date of first treatment to the date of best overall response before surgery, assessed up to 6 months
objective remission rate
From date of first treatment to the date of best overall response before surgery, assessed up to 6 months

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

Eye & ENT Hospital of Fudan University

合作者

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

调查人员

  • 首席研究员：Hongmeng Yu, MD,PhD、Eye& ENT Hospital of Fudan University, Shanghai, China

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 (预期的)

2021年8月10日

初级完成 (预期的)

2025年8月10日

研究完成 (预期的)

2025年8月10日

研究注册日期

首次提交

2021年7月18日

首先提交符合 QC 标准的

2021年8月16日

首次发布 (实际的)

2021年8月17日

研究记录更新

最后更新发布 (实际的)

2021年8月17日

上次提交的符合 QC 标准的更新

2021年8月16日

最后验证

2021年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SNMM-SA-RTNeo

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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