评估乳腺癌辅助超大分割放疗的有效性和毒性
2024年4月2日 更新者：Prevent Senior Institute
评估辅助超大分割放疗治疗早期和局部晚期乳腺癌的有效性和毒性的 II 期研究
前瞻性 2 期研究，旨在评估 65 岁以上患者接受 5 次 5.7 Gy 超大分割辅助放疗的安全性和有效性。
研究概览
详细说明
前瞻性 2 期非随机单臂研究，以评估 65 岁以上患者超大分割辅助放疗在 5 次 5.7 Gy 中的安全性和有效性。
研究类型
介入性
注册 (实际的)
60
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。
学习地点
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São Paulo、巴西
- Instituto de Pesquisa Prevent Senior
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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
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 女性患者；
- 无论组织学亚型和激素水平如何，浸润性乳腺癌的病理学确认；
- 年龄大于或等于65岁；
- 有或没有腋窝入路的保乳手术或乳房切除术
- 有或没有新辅助或辅助全身治疗
排除标准：
- 既往接受过胸部照射的患者；
- 有双侧胸部照射指征的患者；
- 使用假体或自体组织进行乳房重建的患者；
- 切除后手术切缘受损的患者；
- 接受根治性乳房切除术的 pT1-pT2 pN0 患者。
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 |
|---|---|
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实验性的：单臂超低分割
每隔一天在乳房或胸壁区域进行 5 次 5.7 Gy，包括或不包括区域淋巴结引流链
|
辅助超大分割放疗治疗早期和局部晚期乳腺癌
|
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 |
|---|---|---|
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急性毒性
大体时间：长达 3 个月的放疗事件
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急性皮肤毒性的评估标准遵循不良事件标准通用术语标准 - CTCAE v 5.0
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长达 3 个月的放疗事件
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迟发性毒性
大体时间：放疗完成 3 个月后的事件
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根据放射治疗肿瘤学组 (RTOG) 分类评估迟发性皮肤和皮下毒性。
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放疗完成 3 个月后的事件
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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局部区域自由生存
大体时间：3年
|
从开始治疗之日起至局部区域疾病证据复发或进展之日
|
3年
|
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遥远的自由生存
大体时间：3年
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从开始治疗之日起至远处疾病证据进展之日
|
3年
|
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总生存期
大体时间：3年
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定义为从开始治疗之日起至患者死亡
|
3年
|
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美容改变
大体时间：治疗结束后第10周和第26周
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使用Harvard/NSABP/RTOG 量表进行评估。 哈佛/NSABP/RTOG 量表评分是一个 4 分制的乳房美容量表，由临床医生在基线（手术后）和随访期间额外进行两次评估。
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治疗结束后第10周和第26周
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QOL（生活质量）变化
大体时间：3年
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使用 EORTC（欧洲癌症研究与治疗组织）提出的量表进行评估。 EORTC QOQ-C30 和 EORTC QLQ-BR-23 量表。 所有量表和单项测量的分数范围为 0 到 100。 高量表分数代表较高的响应水平。 因此，功能量表的高分代表高/健康的功能水平，整体健康状况/生活质量的高分代表高生活质量，但症状量表/项目的高分代表高水平的症状/问题。 |
3年
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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乳房体积与毒性关系
大体时间：3年
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我们分析了 CTV（临床目标体积）体积（代表乳房大小）和剂量测定数据的影响，特别关注最大剂量和均匀剂量（定义为暴露于 ≥100%、≥处方剂量的 104% 和 ≥107%
|
3年
|
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。
调查人员
- 首席研究员：Marcel MF Fang, MD、Instituto de Pesquisa Prevent Senior
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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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)
2019年1月30日
初级完成 (实际的)
2021年2月11日
研究完成 (实际的)
2023年4月1日
研究注册日期
首次提交
2023年4月20日
首先提交符合 QC 标准的
2023年4月30日
首次发布 (实际的)
2023年5月9日
研究记录更新
最后更新发布 (实际的)
2024年4月4日
上次提交的符合 QC 标准的更新
2024年4月2日
最后验证
2024年4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.