Breast Cancer Clinical Trial
Official title:
Postoperative External Beam Whole Breast or Chest Wall Irradiation of Patients With Breast Cancer in Extreme Hypofractionation.
Verified date | July 2022 |
Source | University of Erlangen-Nürnberg Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Evaluation of treatment toxicity of extreme hypofractionation of the whole breast in five fractions of 5.2 Gy in five consecutive workdays.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | July 30, 2035 |
Est. primary completion date | July 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Erlangen-Nürnberg Medical School |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and grade of Treatment related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0) | Evaluation during treatment and at each follow-up visit up to 10 years | 08/2022 - 07/2035 | |
Secondary | Cosmetic results according to the Harvard-scale | 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 | |
Secondary | In-breast recurrence rate | Evaluation at each follow-up up to 10 years via regular examinations including mammography/ ultrasound | 05/2022 - 04/2035 | |
Secondary | Quality of life during and after treatment using the patient-reported questionnaires EORTC QLQ-C30 and QLQ-BR23 | 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 | |
Secondary | Immune status analysis: Immunophenotyping using peripheral blood at several time points | 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 | |
Secondary | Overall survival | Evaluation at each follow-up up to 10 years | 05/2022 - 04/2035 | |
Secondary | Evaluation of feasibility of breath-hold radiation technique throughout the treatment time | Evaluation of patient's capability to follow breathing commandos during planning-CT scan and each application of radiotherapy | 05/2022 - 04/2025 |
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