乳腺癌局部复发后的术中放疗 (RE-IORT01)
2023年10月31日 更新者：Institut du Cancer de Montpellier - Val d'Aurelle
乳腺癌局部复发后术中放疗（IORT）与二次保乳手术的可行性临床试验
研究人员提出了一项前瞻性、多中心、单臂 II 期设计，以评估在乳腺癌局部复发后重复保乳手术联合使用 IORT 再照射的可行性。
研究概览
详细说明
目前，保乳手术和放疗后同侧乳腺肿瘤复发率 (IBTR) 分别保持在 10 年的 10% 和 20 年的 15%。 IBTR 是生存率低下的独立预测因子，癌症相关死亡风险增加 3 至 4.6 倍。
在异质人群中，局部控制仍然是这些复发的主要治疗挑战，尤其是那些被认为预后较好的复发，即发生较晚且组织学分级较低的复发。 可以对这些复发进行治疗降级，以避免毁伤性且通常是创伤性的乳房切除术。
然而，由于没有再照射，这第二次保守手术的二次局部复发率很高（5 年时为 19% 至 50%），由于先前受照射组织的耐受性问题而变得不可能。
在辅助环境下对部分乳房照射 (PBI) 进行的回顾性或前瞻性研究报告了有希望的结果，无论是在耐受性（保留健康组织）还是局部控制（5 年时为 74% 至 100%）方面。 使用的技术包括近距离放射治疗、外照射放射治疗和术中放射治疗 (IORT)。
IORT 现在是重新引起人们对乳腺癌兴趣的主题。 它具有对手术区域进行高精度弹道和保存健康组织的优点。 然而，迄今为止，还没有关于同侧乳房复发指征的前瞻性数据发表。
一项前瞻性、多中心、单臂 II 期设计将评估在乳腺癌局部复发后重复保乳手术联合使用 IORT 再照射的可行性。
研究类型
介入性
注册 (实际的)
66
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。
学习地点
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-
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Bordeaux、法国、33000
- Institut Bergonié
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Brest、法国
- Chu Brest
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Dijon、法国
- Centre George Francois Leclerc
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Lyon、法国、69
- Centre Léon Bérard
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Marseille、法国、13
- CHU La Timone
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Marseille、法国、13
- Institut Paoli Calmette
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Montpellier、法国、34298
- ICM
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Nantes、法国
- Institut de Cancerologie de l'Ouest
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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
50年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 组织学证实的非小叶浸润性乳腺复发
- 初次乳房肿瘤切除术后全乳放疗的时间 >5 年
- 单灶性肿瘤
- 复发肿瘤大小≤ 2 cm
- 适合二次保乳手术且美容效果可接受的乳房大小
- 进入研究前 90 天内的双侧乳房 X 线照片
- 进入研究前 90 天内的乳房 MRI 检查
- 组织学分级 I-II
- 雌激素受体阳性肿瘤 (ER+)
- Cerb2 阴性肿瘤
- N0
- M0
- 在标准分割计划内进行的先前放疗
- 体能状态（ECOG）0-1
- ≥ 50 岁的女性 - 没有任何可能妨碍遵守研究和随访计划的心理、家庭、社会或地理条件
- 隶属于法国健康保险制度
- 书面并签署知情同意书。
排除标准：
- 多灶性和/或多中心复发
- 小叶癌
- 雌激素受体阴性肿瘤 (ER-)
- Cerb2 (her2) 过度表达 - 乳腺癌
- 活检广泛导管内成分 (EIC)
- 活检淋巴管浸润
- N1-3 状态：区域细胞学或组织学证实的淋巴结复发
- M1 状态：转移性疾病
- cT4（皮肤或肌肉受累）或乳头佩吉特病
- 在加速或低分割计划内进行的先前放疗
- 非黑色素瘤皮肤癌以外的既往恶性肿瘤，除非患者已至少 5 年无病
- 乳房体积小，技术上不能满足二次保守手术或术中乳房照射的患者。
- 局部复发的术前化疗或激素治疗
- 结缔组织病或硬皮病，禁忌放疗
- 已知的 BRCA1/2 基因突变（不需要进行基因检测）
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：手术和术中放疗
外科手术 ： 肿瘤切除术将根据现行标准进行，获得“清晰”的边缘。 腋窝淋巴结控制将取决于团队选择的这些 N0 患者的初始管理（临床和超声）。 术中放疗 (IORT)： 切除肿瘤后，将进行 IORT。 将在肿瘤床上施用单剂量 20 Gy x 50 kV 光子 (Intrabeam™)。 添加 IORT 不会改变手术过程。 |
肿瘤切除术将根据现行标准进行，获得“清晰”的边缘。
腋窝淋巴结控制将取决于团队选择的这些 N0 患者的初始管理（临床和超声）。
切除肿瘤后，将进行 IORT。
将在肿瘤床上施用单剂量 20 Gy x 50 kV 光子 (Intrabeam™)。
添加 IORT 不会改变手术程序
|
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 |
|---|---|---|
|
乳腺癌第二次保守治疗后局部延迟复发患者对 RIOP（术中放疗）的耐受性
大体时间：辐射后 12 个月内
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根据 NCI CTCAE v4.0 分类，IORT（术中放疗）12 个月时 RIOP 2 级纤维化率
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辐射后 12 个月内
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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通过摄影评估美容效果
大体时间：治疗前、治疗15天、治疗3、6、12和24个月时
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审美评价（照片）
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治疗前、治疗15天、治疗3、6、12和24个月时
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早期和晚期毒性发生率
大体时间：从基线到治疗后 5 年
|
早期毒性发生率（血肿、淋巴漏、乳房感染） 晚期毒性（毛细血管扩张、乳房疼痛、皮肤色素沉着、皮肤溃疡、皮肤萎缩）
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从基线到治疗后 5 年
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局部无复发生存期
大体时间：从基线到治疗后 5 年
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从基线到出现局部复发的时间
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从基线到治疗后 5 年
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无转移复发生存期
大体时间：从基线到治疗后 5 年
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从基线到出现转移复发的时间
|
从基线到治疗后 5 年
|
|
无病生存。
大体时间：从基线到治疗后 5 年
|
无复发时间
|
从基线到治疗后 5 年
|
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总体生存率
大体时间：从基线到治疗后 5 年
|
从基线到出现复发的时间
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从基线到治疗后 5 年
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自由间隔无需乳房切除术。
大体时间：从基线到治疗后 5 年
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从基线到乳房切除术的时间
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从基线到治疗后 5 年
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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
- 学习椅：LEMANSKI Claire、Institut régional du Cancer - Val d'Aurelle
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。
一般刊物
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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)
2014年3月1日
初级完成 (实际的)
2020年6月12日
研究完成 (实际的)
2023年9月18日
研究注册日期
首次提交
2015年3月2日
首先提交符合 QC 标准的
2015年3月10日
首次发布 (估计的)
2015年3月11日
研究记录更新
最后更新发布 (实际的)
2023年11月1日
上次提交的符合 QC 标准的更新
2023年10月31日
最后验证
2023年10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.