Postoperative External Beam Whole Breast or Chest Wall Irradiation of Patients With Breast Cancer in Extreme Hypofractionation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Incidence and grade of Treatment related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
研究概览
简要总结
Evaluation of treatment toxicity of extreme hypofractionation of the whole breast in five fractions of 5.2 Gy in five consecutive workdays.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence and grade of Treatment related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
时间窗: 08/2022 - 07/2035
Evaluation during treatment and at each follow-up visit up to 10 years
次要结局
- Cosmetic results according to the Harvard-scale(05/2022 - 04/2035)
- Evaluation of feasibility of breath-hold radiation technique throughout the treatment time(05/2022 - 04/2025)
- In-breast recurrence rate(05/2022 - 04/2035)
- Overall survival(05/2022 - 04/2035)
- Quality of life during and after treatment using the patient-reported questionnaires EORTC QLQ-C30 and QLQ-BR23(05/2022 - 04/2035)
- Immune status analysis: Immunophenotyping using peripheral blood at several time points(05/2022 - 04/2027)
研究者
Claudia Schweizer
Dr. med. Claudia Schweizer
University of Erlangen-Nürnberg Medical School