Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.
2022年7月6日 更新者：Claudia Schweizer、University of Erlangen-Nürnberg Medical School
Postoperative External Beam Whole Breast or Chest Wall Irradiation of Patients With Breast Cancer in Extreme Hypofractionation.
Evaluation of treatment toxicity of extreme hypofractionation of the whole breast in five fractions of 5.2 Gy in five consecutive workdays.
研究概览
地位
尚未招聘
条件
详细说明
The focus of this phase 2-trial is set on feasibility as well as early and late toxicity rates. One possible disadvantage of extreme hypofractionation could be an increased rate of fibrosis within the irradiated region. Therefore, a closer look will be taken with this prospective trial.
In addition, we are planning an accompanying translational research program since hypofractionated schedules are suggested to be more immunogenic in breast cancer.
Secondary objectives therefore are: cosmetic outcome, local tumor control, quality of life, dynamic immune status, importance of tumor infiltrating immune cells, overall survival, disease-free survival, feasibility of breath-hold radiation technique.
研究类型
观察性的
注册 (预期的)
100
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
女性
取样方法
非概率样本
研究人群
Patients with breast cancer after complete resection and the indication for postoperative radiotherapy.
描述
Inclusion Criteria:
- Histologically confirmed invasive breast cancer or ductal carcinoma in situ (DCIS)
- pT-category pT0-3
- complete resection (R0)
- Absence of distant metastasis (M0)
- Absence of contralateral breast cancer/ DCIS
- Karnofsky Performance Score ≥ 60%
- Age ≥ 18 years at time of study entry
- Written informed consent
Exclusion Criteria:
- All patients not fulfilling inclusion criteria
- Morbus Paget or pathological skin infiltration
- Earlier or synchronous breast cancer
- Pregnant or breast-feeding women
- Increased radiosensitivity or any genetic disposition for increased radiosensitivity, e.g. ataxia telangiectatica
- Judgement by the investigator that the patient is unlikely to comply with study procedures and requirements
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
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 |
|---|---|---|
|
Incidence and grade of Treatment related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
大体时间：08/2022 - 07/2035
|
Evaluation during treatment and at each follow-up visit up to 10 years
|
08/2022 - 07/2035
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cosmetic results according to the Harvard-scale
大体时间：05/2022 - 04/2035
|
Clinical evaluation of the irradiated breast at each follow-up up to 10 years according to the Harvard-scale (patient's and physician's view)
|
05/2022 - 04/2035
|
|
In-breast recurrence rate
大体时间：05/2022 - 04/2035
|
Evaluation at each follow-up up to 10 years via regular examinations including mammography/ ultrasound
|
05/2022 - 04/2035
|
|
Quality of life during and after treatment using the patient-reported questionnaires EORTC QLQ-C30 and QLQ-BR23
大体时间：05/2022 - 04/2035
|
Evaluation of patient's quality of life from inclusion to each follow-up up to 10 years via standardized questionnaires: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 and the breast-orientated QLQ-BR23
|
05/2022 - 04/2035
|
|
Immune status analysis: Immunophenotyping using peripheral blood at several time points
大体时间：05/2022 - 04/2027
|
Withdrawals of whole blood (plasma and serum) before the first irradiation until one year after the treatment.
Immunophenotyping by a modular multicolor flow cytometry-based method.
Furthermore, whole exome sequencing/RNASeq on already obtained tissue from the breast surgery.
|
05/2022 - 04/2027
|
|
Overall survival
大体时间：05/2022 - 04/2035
|
Evaluation at each follow-up up to 10 years
|
05/2022 - 04/2035
|
|
Evaluation of feasibility of breath-hold radiation technique throughout the treatment time
大体时间：05/2022 - 04/2025
|
Evaluation of patient's capability to follow breathing commandos during planning-CT scan and each application of radiotherapy
|
05/2022 - 04/2025
|
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 (预期的)
2022年8月1日
初级完成 (预期的)
2025年7月30日
研究完成 (预期的)
2035年7月30日
研究注册日期
首次提交
2022年4月22日
首先提交符合 QC 标准的
2022年7月6日
首次发布 (实际的)
2022年7月11日
研究记录更新
最后更新发布 (实际的)
2022年7月11日
上次提交的符合 QC 标准的更新
2022年7月6日
最后验证
2022年7月1日
更多信息
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