加速放射治疗 (PRART) 的前瞻性随机研究 (PRART)
2026年5月5日 更新者：Weill Medical College of Cornell University
加速放射治疗 (PRART) 的前瞻性随机研究：一项比较乳房美容和局部控制的非劣效性试验，以比较在三周内进行 15 次分次放疗（第 1 组，标准）与两周内进行 10 次分次（第 2 组，实验性的）
患有 0 期导管原位癌（Tis (DCIS)、T1-T2 期、淋巴结阴性 (N0) 乳腺癌）的患者将被随机分配接受全乳放疗，同时对瘤床进行超过 15 次分割（第 1 组，标准）与 10 个分数（第 2 组，实验）。
研究概览
研究类型
介入性
注册 (实际的)
397
阶段
- 第三阶段
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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New York
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New York、New York、美国、11215
- Brooklyn Methodist Hospital - NewYork Presbyterian
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New York、New York、美国、11355
- New York Presbyterian Hospital - Queens
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New York、New York、美国、10007
- New York Presbyterian Hospital at Lower Manhattan Cancer Center
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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
19年 至 90年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 乳房节段切除术后的女性状况
- 如果是单侧 pT1-2 乳腺癌，切缘阴性
- 如果是双侧，pT1-2 乳腺癌切缘阴性和/或 pTis 切缘阴性。
- 临床上 N0 或 pN0 或前哨淋巴结阴性
- 边缘为阴性的导管原位癌 DCIS（墨迹边缘无 DCIS）。
排除标准：
- 先前对同侧乳房进行过放射治疗。
- 自上次手术后 90 天，除非 s/p 辅助化疗
- 最后一次化疗后 60 天
- 男性乳腺癌
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 |
|---|---|
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实验性的：ARM 1-4050cGY 并分 15 次推量至瘤床 4800cGY
随机分配至 ARM 1 的患者将接受 4050cGY 的全乳放疗，并伴随分 15 次对肿瘤床进行 4800cGY 的推量
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随机分配至 ARM 1 的患者将接受 4050cGY 的全乳放疗，并伴随分 15 次对肿瘤床进行 4800cGY 的推量
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实验性的：ARM 2 - 3200cGY 和推量至瘤床 4200cGY -10 次
随机分配至 ARM 2 的患者将接受 3200cGY 的全乳放疗，并伴随分 10 次对肿瘤床进行 4200cGY 的推量。
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随机分配至 ARM 2 的患者将接受 3200cGY 的全乳放疗，并伴随分 10 次对肿瘤床进行 4200cGY 的推量。
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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 |
|---|---|---|
|
Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 10-fraction Arm Compared to Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 15-fraction Arm Evaluated up to 1-month Post-radiation Treatment
大体时间：up to 1-month post-radiation treatment
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Proportion of grade ≥ 2 of acute toxicity defined according to the Common Terminology Criteria for Adverse Events (CTCAEs) - version 5.0, on the 10-fraction arm compared to the rate on the 15-fraction arm will be measured, up to 1-month post-radiation treatment.
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up to 1-month post-radiation treatment
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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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Proportion of Patients With Local Breast Cancer Control on the 10-fraction Arm Compared to Proportion of Patients With Local Breast Cancer Control on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment
大体时间：2-3 years
|
Assess and compare local control at 2-3 years between the two arms.
At each post treatment follow-up visit, a physical exam to detect breast clinical recurrence will be performed.
Mammographic studies and/or breast MRI will be performed and reviewed on an annual basis, according to the standard care.
Local control will be defined according to the findings from physical exam, mammographic studies and/or breast MRI.
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2-3 years
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Proportion of Patients With Local Breast Cancer Control on the 10-fraction Arm Compared to Proportion of Patients With Local Breast Cancer Control on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment
大体时间：5 years
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Assess and compare local control at 5 years between the two arms.
At each post treatment follow-up visit, a physical exam to detect breasts clinical disease recurrence will be performed.
Mammographic studies and/or breast MRI will be performed and reviewed on an annual basis, according to the standard care.
Local control will be defined according to the findings from physical exam, mammographic studies and/or breasts MRI.
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5 years
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Number of Subjects With Fibrosis Defined Per Grades According to LENT/SOMA Fibrosis Scoring System on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment
大体时间：2-3 years
|
Assess and compare fibrosis at 2-3 years between the two arms.
At each post treatment follow-up visit, the fibrosis will be assessed by breasts palpation performed by the physician or nurse practitioner and will be measured as per LENT/SOMA fibrosis scoring system.
According to this scoring system, fibrosis is categorized into three grades (Grade 1, Grade 2 and Grade 3), where Grade 1 is defined as "barely palpable, increased density" and Grade 3 is defined as "very marked density, retraction, and fixation".
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2-3 years
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Number of Subjects Reporting Breast Cosmesis According to BCTOS Questionnaire on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 2-3 Years Post-radiation Treatment
大体时间：2-3 years
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Assess and compare breast cosmesis at 2-3 years between the two arms.
At each post treatment follow-up visit, breast cosmesis will be self-assessed by the patient using Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires.
According to this scale, breast cosmesis is evaluated using a four-point system (Point 1, Point 2, Point 3, and Point 4), where Point 1 is defined as "no change compared to the untreated breast" and Point 4 as "large change compared to the untreated breast."
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2-3 years
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Number of Subjects With Fibrosis Defined Per Grades According to LENT/SOMA Fibrosis Scoring System on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment
大体时间：5 years
|
Assess and compare fibrosis at 5 years between the two arms.
At each post treatment follow-up visit, the fibrosis will be assessed by breasts palpation performed by the physician or nurse practitioner and will be measured as per LENT/SOMA fibrosis scoring system.
According to this scoring system, fibrosis is categorized into three grades (Grade 1, Grade 2 and Grade 3), where Grade 1 is defined as "barely palpable, increased density" and Grade 3 is defined as "very marked density, retraction, and fixation".
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5 years
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Number of Subjects Reporting Breast Cosmesis According to BCTOS Questionnaire on the 10-fraction Arm and on the 15-fraction Arm Evaluated at 5 Years Post-radiation Treatment
大体时间：5 years
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Assess and compare breast cosmesis at 5 years between the two arms.
At each post treatment follow-up visit, breast cosmesis will be self-assessed by the patient using Breast Cancer Treatment Outcome Scale (BCTOS) questionnaires.
According to this scale, breast cosmesis is evaluated using a four-point system (Point 1, Point 2, Point 3, and Point 4), where Point 1 is defined as "no change compared to the untreated breast" and Point 4 as "large change compared to the untreated breast."
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5 years
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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
- 首席研究员：Silvia Formenti, M.D.、Weill Medical College of Cornell University
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11月21日
初级完成 (实际的)
2025年7月15日
研究完成 (估计的)
2030年6月30日
研究注册日期
首次提交
2019年11月20日
首先提交符合 QC 标准的
2019年11月21日
首次发布 (实际的)
2019年11月22日
研究记录更新
最后更新发布 (实际的)
2026年5月7日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2026年5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.