The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.
A total of twenty-five patients will be treated with a single dose preoperative ablative radiation treatment. After a vigilant follow-up with MRI, breast conserving surgery will be performed 6 months after the ablative radiation treatment. The total follow-up time is 10 years. This study aims to present an ablative radiotherapy treatment approach that could resolve to some extent the disadvantages of current breast conserving treatment in elderly low-risk breast cancer patients who are currently not treated according to guidelines due to co-morbidity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
A single dose ablative radiotherapy will be delivered prior to surgery
University Medical Center Utrecht
Utrecht, Netherlands
Pathological complete response
Time frame: 6 months after radiotherapy
Radiological tumor response on MRI according to the RECIST criteria
Time frame: Within 1 week and 2, 4 and 6 months after radiotherapy
Radiological tumor response on FDG-PET-CT according to the PERCIST criteria
Time frame: At 6 months after radiotherapy
Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires
Time frame: Until 10 years after radiotherapy
Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software
Time frame: Until 10 years after radiotherapy
Frailty assessment according to the Groningen Frailty Indicator
Time frame: Until 10 years after radiotherapy
Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire.
Time frame: Until 10 years after radiotherapy
Local relapse rates
Time frame: Until 10 years after radiotherapy
Regional relapse rates
Time frame: Until 10 years after radiotherapy
Distant relapse rates
Time frame: Until 10 years after radiotherapy
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Disease free survival
Time frame: Until 10 years after radiotherapy
Overall survival
Time frame: Until 10 years after radiotherapy