Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer
2026年8月19日 更新者:Chaosu Hu、Fudan University
Selective Coverage Versus Comprehensive Coverage Radiotherapy in Poorly Differentiated and Anaplastic Thyroid Cancer: A Randomized, Controlled, Non-inferiority, Phase 2 Study
To explore the efficacy and safety of selective coverage radiotherapy in poorly differentiated and anaplastic thyroid cancer
研究概览
详细说明
To explore that selective coverage radiotherapy is non-inferior to comprehensive coverage radiotherapy in terms of locoregional control rate at 12 months in poorly differentiated and anaplastic thyroid cancer, while reducing radiotherapy-related toxicity and improving quality of life.
研究类型
介入性
注册 (估计的)
72
阶段
- 阶段2
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:Xiayun He, MD
- 电话号码:+86021-64175590-81412
- 邮箱:hexiayun1962@163.com
研究联系人备份
- 姓名:Fen Xue, MD
- 邮箱:dr_fenxue@163.com
学习地点
-
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200032
- 招聘中
- Fudan Universtiy Shanghai Cancer Center
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接触:
- Xiayun He, MD
- 电话号码:+86021-64175590-81412
- 邮箱:hexiayun1962@163.com
-
接触:
- Fen Xue, MD
- 邮箱:dr_fenxue@163.com
-
-
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:
- Age ≥ 18 years old
- Pathologically confirmed as ATC, thyroid cancer containing ATC components, PDTC (in accordance with Turin criteria), or other thyroid cancers with poorly differentiated components, and the MDT considers the biological behavior similar to PDTC.
- Evaluated by the MDT and proposed to receive external beam radiotherapy, including postoperative R0/R1, R2 gross residual, inoperable local lesion, and local recurrence.
- ECOG performance status 0-2
- expected survival ≥ 3 months
- major organ functions can meet the requirements for radiotherapy and the proposed systemic treatment.
- The subject voluntarily participates in the study and signs a written informed consent form, willing to follow up according to the protocol and fill in the quality of life scale.
Exclusion Criteria:
- Has received radiotherapy to the head and neck or upper mediastinum region in the past, and the target area of this study overlaps significantly with it, and the normal tissue limit cannot be met.
- Has severe uncontrolled infections, active bleeding, unaddressed airway crises, severe dysfunction of the heart, lungs, liver, kidneys or other diseases that cannot be safely treated with radiotherapy.
- Pregnant or lactating women; women of childbearing age who do not agree to take effective contraceptive measures.
- Has other active malignant tumors within 5 years or simultaneously (excluding cured localized tumors such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.)
- Cannot complete radiotherapy fixation, simulation positioning or follow-up imaging assessment.
- Other situations that the researcher deems unsuitable for participation in this study.
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:随机化
- 介入模型:并行分配
- 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:Selective coverage radiotherapy
|
|
|
有源比较器:comprehensive coverage radiotherapy
|
|
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 |
|---|---|---|
|
Locoregional control rate,LRC
大体时间:12 months
|
The time from the randomization date to the first occurrence of locoregional progression/recurrence.
Locoregional regions include the primary thyroid lesion or the postoperative tumor bed, the central region/upper mediastinal related regions, the cervical lymph node region, the retropharyngeal lymph nodes, and the cervical soft tissue contiguous with the original lesion.
12-month LRC is defined as 1 minus the cumulative incidence of locoregional progression over 12 months.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression Free Survival,PFS
大体时间:12 months
|
From the date of randomization to the date of the first recording of tumor PD (evaluated according to the RECIST 1.1) or the date of death due to any cause, whichever comes earlier.
PD includes local regional recurrence/progression and distant metastasis.
|
12 months
|
|
Overall Survival, OS
大体时间:12 months
|
The time from randomization to death due to any cause.
|
12 months
|
|
Disease Control Rate,DCR
大体时间:up to 12 months
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Defined as the proportion of patients with a complete response, partial response and stable Disease to radiotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST).
Applicable to those with measurable lesions.
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up to 12 months
|
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Adverse Events
大体时间:12 months
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All radiotherapy-related adverse events will be documented
|
12 months
|
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Quality of Life (QoL) by EORTC QLQ-H&N35 questionnaire.
大体时间:12 months
|
Changes in QoL of participants from baseline to up to 12 months after the radiotherapy.
Use EORTC QLQ-H&N35 questionnaire.
|
12 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。
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 (实际的)
2026年8月12日
初级完成 (估计的)
2031年7月31日
研究完成 (估计的)
2032年7月31日
研究注册日期
首次提交
2026年8月16日
首先提交符合 QC 标准的
2026年8月19日
首次发布 (实际的)
2026年8月20日
研究记录更新
最后更新发布 (实际的)
2026年8月20日
上次提交的符合 QC 标准的更新
2026年8月19日
最后验证
2026年8月1日
更多信息
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.