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Radiation Therapy in Treating Patients With Recurrent Breast Cancer

2020年8月6日更新者：Case Comprehensive Cancer Center

Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.

PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.

研究概览

地位

完全的

条件

乳腺癌

干预/治疗

详细说明

OBJECTIVES:

To determine the in breast recurrence rate following repeat radiation to the breast. These patients will be followed for a period of five years following completion of radiation to determine these rates.
To determine the cosmetic outcome resulting from partial breast re-irradiation using different techniques, including both physician and patient rated scales.
To determine patient satisfaction of partial breast re-irradiation as it pertains to their overall treatment experience, as measured by a questionnaire.
To determine if there are patient factors illuminated during a discussion of informed consent, which limit a patient's suitability to receive partial breast re-irradiation delivered by a particular technique.
To evaluate tylectomy wound healing and overall complication rate after partial breast re-irradiation.
To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.These patients will be followed for a period of five years following completion of the second course of radiation to determine these rates.

OUTLINE: Patients are stratified according to which modality is best suited for the patient. Patients are assigned to 1 of 2 groups.

All patients undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity.

Group 1: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
Group 2: Patients undergo partial breast irradiation delivered by Mammosite® brachytherapy consisting of 10 fractions over 5 days.

Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then at follow-up visits.

After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years.

研究类型

介入性

注册 (实际的)

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

美国
- Ohio
  - Cleveland、Ohio、美国、44106-5065
    - University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
  - Cleveland、Ohio、美国、44122
    - UHHS Chagrin Highlands Medical Center
  - Cleveland、Ohio、美国、44145
    - UHHS Westlake Medical Center

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:

Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)
Unifocal breast cancer recurrence
Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision
Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.
Signed study-specific informed consent prior to study entry.

Exclusion Criteria:

Patients with distant metastatic disease
Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.
Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.
Patients with Paget's disease of the nipple.
Patients with skin involvement.
Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.
Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study.
Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.
Patients with known BReast CAncer gene (BRCA)1/BRCA 2 mutations.

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：非随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Intraoperative radiation therapy Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.	辐射：intraoperative radiation therapy Patients undergo radiotherapy
实验性的：Intracavitary balloon brachytherapy Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.	辐射：intracavitary balloon brachytherapy Patients undergo brachytherapy

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
Ipsilateral Breast Tumor Recurrence Rates 大体时间：1 month after radiation therapy (RT)	Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.	1 month after radiation therapy (RT)
Ipsilateral Breast Tumor Recurrence Rates 大体时间：3 months after RT	Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.	3 months after RT
Ipsilateral Breast Tumor Recurrence Rates 大体时间：6 months after RT	Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.	6 months after RT
Ipsilateral Breast Tumor Recurrence Rates 大体时间：9 months after RT	Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.	9 months after RT
Ipsilateral Breast Tumor Recurrence Rates 大体时间：12 months after RT	Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.	12 months after RT
Ipsilateral Breast Tumor Recurrence Rates 大体时间：2 years after RT	Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.	2 years after RT
Ipsilateral Breast Tumor Recurrence Rates 大体时间：3 years after RT	Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.	3 years after RT
Ipsilateral Breast Tumor Recurrence Rates 大体时间：4 years after RT	Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.	4 years after RT
Ipsilateral Breast Tumor Recurrence Rates 大体时间：5 years after RT	Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.	5 years after RT
Tumor Bed Recurrence Rates 大体时间：1 month after RT	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	1 month after RT
Tumor Bed Recurrence Rates 大体时间：3 month after RT	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	3 month after RT
Tumor Bed Recurrence Rates 大体时间：6 month after RT	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	6 month after RT
Tumor Bed Recurrence Rates 大体时间：12 month after RT	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	12 month after RT
Tumor Bed Recurrence Rates 大体时间：2 years after RT	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	2 years after RT
Tumor Bed Recurrence Rates 大体时间：3 years after RT	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	3 years after RT
Tumor Bed Recurrence Rates 大体时间：4 years after RT	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	4 years after RT
Tumor Bed Recurrence Rates 大体时间：5 years after RT	Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision	5 years after RT
Cosmetic Outcome as Determined by an Established Scale 大体时间：1 month after RT & Q3mos for one year and at 5 years	Cosmetic outcome as determined by four-level scale of cosmetic outcome scale, with levels poor, fair, good, and excellent in increasingly positive outcomes. Excellent: Minimal or no difference in the size or shape of the treated breast Good: Slight difference in the size or shape of the treated breast Fair: Obvious difference in the shape and size of the treated breast Poor: Obvious difference in the shape and size of the treated breast	1 month after RT & Q3mos for one year and at 5 years
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey 大体时间：1 month after RT	Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" I am totally satisfied with the treatment and results I am not totally satisfied but would choose the same treatment again. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. I am dissatisfied with my treatment.	1 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey 大体时间：3 month after RT	Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" I am totally satisfied with the treatment and results I am not totally satisfied but would choose the same treatment again. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. I am dissatisfied with my treatment.	3 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey 大体时间：6 month after RT	Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" I am totally satisfied with the treatment and results I am not totally satisfied but would choose the same treatment again. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. I am dissatisfied with my treatment.	6 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey 大体时间：9 month after RT	Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" I am totally satisfied with the treatment and results I am not totally satisfied but would choose the same treatment again. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. I am dissatisfied with my treatment.	9 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey 大体时间：12 month after RT	Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" I am totally satisfied with the treatment and results I am not totally satisfied but would choose the same treatment again. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. I am dissatisfied with my treatment.	12 month after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey 大体时间：2 years after RT	Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" I am totally satisfied with the treatment and results I am not totally satisfied but would choose the same treatment again. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. I am dissatisfied with my treatment.	2 years after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey 大体时间：3 years after RT	Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" I am totally satisfied with the treatment and results I am not totally satisfied but would choose the same treatment again. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. I am dissatisfied with my treatment.	3 years after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey 大体时间：4 years after RT	Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" I am totally satisfied with the treatment and results I am not totally satisfied but would choose the same treatment again. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. I am dissatisfied with my treatment.	4 years after RT
Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey 大体时间：5 years after RT	Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey Participants indicate level of satisfaction by answering "my satisfaction about the treatment and results is" I am totally satisfied with the treatment and results I am not totally satisfied but would choose the same treatment again. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again. I am dissatisfied with my treatment.	5 years after RT
Percent of Participants Experiencing Complications After Intervention 大体时间：1 month after RT	Overall complication rate, as measured by percent of participants experiencing complications after intervention	1 month after RT
Percent of Participants Experiencing Complications After Intervention 大体时间：3 month after RT	Overall complication rate, as measured by percent of participants experiencing complications after intervention	3 month after RT
Percent of Participants Experiencing Complications After Intervention 大体时间：6 month after RT	Overall complication rate, as measured by percent of participants experiencing complications after intervention	6 month after RT
Percent of Participants Experiencing Complications After Intervention 大体时间：9 month after RT	Overall complication rate, as measured by percent of participants experiencing complications after intervention	9 month after RT
Percent of Participants Experiencing Complications After Intervention 大体时间：12 month after RT	Overall complication rate, as measured by percent of participants experiencing complications after intervention	12 month after RT
Percent of Participants Experiencing Complications After Intervention 大体时间：2 years after RT	Overall complication rate, as measured by percent of participants experiencing complications after intervention	2 years after RT
Percent of Participants Experiencing Complications After Intervention 大体时间：3 years after RT	Overall complication rate, as measured by percent of participants experiencing complications after intervention	3 years after RT
Percent of Participants Experiencing Complications After Intervention 大体时间：4 years after RT	Overall complication rate, as measured by percent of participants experiencing complications after intervention	4 years after RT
Percent of Participants Experiencing Complications After Intervention 大体时间：5 years after RT	Overall complication rate, as measured by percent of participants experiencing complications after intervention	5 years after RT

次要结果测量

结果测量	措施说明	大体时间
Percent of Participants With Delayed Wound Healing 大体时间：1 month after RT	Wound healing rate, as measured by percent of participants with delayed wound healing	1 month after RT
Percent of Participants With Delayed Wound Healing 大体时间：3 month after RT	Wound healing rate, as measured by percent of participants with delayed wound healing	3 month after RT
Percent of Participants With Delayed Wound Healing 大体时间：6 month after RT	Wound healing rate, as measured by percent of participants with delayed wound healing	6 month after RT
Percent of Participants With Delayed Wound Healing 大体时间：9 month after RT	Wound healing rate, as measured by percent of participants with delayed wound healing	9 month after RT
Percent of Participants With Delayed Wound Healing 大体时间：12 month after RT	Wound healing rate, as measured by percent of participants with delayed wound healing	12 month after RT
Percent of Participants With Delayed Wound Healing 大体时间：2 years after RT	Wound healing rate, as measured by percent of participants with delayed wound healing	2 years after RT
Percent of Participants With Delayed Wound Healing 大体时间：3 years after RT	Wound healing rate, as measured by percent of participants with delayed wound healing	3 years after RT
Percent of Participants With Delayed Wound Healing 大体时间：4 years after RT	Wound healing rate, as measured by percent of participants with delayed wound healing	4 years after RT
Percent of Participants With Delayed Wound Healing 大体时间：5 years after RT	Wound healing rate, as measured by percent of participants with delayed wound healing	5 years after RT

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

Case Comprehensive Cancer Center

调查人员

首席研究员：Janice Lyons, MD、University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

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)

2008年9月23日

初级完成 (实际的)

2018年7月6日

研究完成 (实际的)

2018年7月6日

研究注册日期

首次提交

2009年7月22日

首先提交符合 QC 标准的

2009年7月22日

首次发布 (估计)

2009年7月23日

研究记录更新

最后更新发布 (实际的)

2020年8月18日

上次提交的符合 QC 标准的更新

2020年8月6日

最后验证

2020年8月1日

intraoperative radiation therapy的临床试验

University of Applied Sciences and Arts of Southern...
Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie

完全的

热疗对恢复和表现的影响 (Cryotherapy)

健康

瑞士
NeuroTronik Inc.

未知

急性心力衰竭的心输出量自主神经刺激疗法 (COAST-AHF)

急性心力衰竭

巴拿马
Abbott Medical Devices

完全的

Therapy™ Cool Path™ Duo 心脏消融系统治疗典型心房扑动 (AFL) 的临床评价

典型心房扑动

美国, 加拿大
NeuroTronik Inc.

未知

心力衰竭的心输出量自主神经刺激疗法 - 血液动力学效应 (COAST-HF FX)

心脏衰竭 | 急性心力衰竭

巴拉圭
Columbia University

终止

Enterra Therapy 胃刺激系统 (Enterra)

胃轻瘫

美国
Vyaire Medical

尚未招聘

Fabian PRICO 用于无创呼吸支持饱和度靶向的安全性和性能的随机、多中心研究

新生儿呼吸功能不全综合征

意大利
Abbott Medical Devices

完全的

Therapy™ Cool Flex 消融导管治疗阵发性房颤的临床评价 (FACT-AF)

阵发性房颤

澳大利亚, 德国, 法国, 意大利, 葡萄牙, 英国
Abbott Medical Devices

终止

治疗酷路径消融 VT (Ablate-VT)

缺血性室性心动过速

美国
University of Southern California
National Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute of Child... 和其他合作者

完全的

手臂康复的大脑和行为相关性 (BCAR)

中风，心血管

美国
Abbott Medical Devices

完全的

用于典型心房扑动的 Therapy™ Cool Flex™ 冲洗消融系统 (FLEXION-AFL)

典型心房扑动

美国, 加拿大

Radiation Therapy in Treating Patients With Recurrent Breast Cancer

Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

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

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (估计)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

intraoperative radiation therapy的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Ireland

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点