Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.
- Conditions
- Breast Cancer
- Registration Number
- NCT05452083
- Lead Sponsor
- University of Erlangen-Nürnberg Medical School
- Brief Summary
Evaluation of treatment toxicity of extreme hypofractionation of the whole breast in five fractions of 5.2 Gy in five consecutive workdays.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and grade of Treatment related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0) 08/2022 - 07/2035 Evaluation during treatment and at each follow-up visit up to 10 years
- Secondary Outcome Measures
Name Time Method Cosmetic results according to the Harvard-scale 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)
Evaluation of feasibility of breath-hold radiation technique throughout the treatment time 05/2022 - 04/2025 Evaluation of patient's capability to follow breathing commandos during planning-CT scan and each application of radiotherapy
In-breast recurrence rate 05/2022 - 04/2035 Evaluation at each follow-up up to 10 years via regular examinations including mammography/ ultrasound
Overall survival 05/2022 - 04/2035 Evaluation at each follow-up up to 10 years
Quality of life during and after treatment using the patient-reported questionnaires EORTC QLQ-C30 and QLQ-BR23 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
Immune status analysis: Immunophenotyping using peripheral blood at several time points 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.