To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy
To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery
Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery
A External Beam Hypofractionated Radiotherapy will be administered after surgery. y. The dose per fraction will be 2.67 Gy per session. EBRT will be performed daily from Monday to Friday for fifteen fractions.
Evelyn Martínez
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGChanges in Cosmetic results - BCCT
It will be measured by the BCCT.core software programme. This software uses 4 photographies of the breast for each timepoint and evaluates cosmetic outcome based upon symmetry, skin colour changes and surgical scar appearance. The lower the calculated score, the better the cosmetic outcome (1=excellent, 2=good, 3=fair, 4=poor)
Time frame: Baseline and every 12 months until 60 months
Changes in Cosmetic results - Self Evaluation using YBT
Questionnaire for cosmetic self-evaluation from the Young Boost Trial (YBT) that consists s of 8 questions about various aspects (size, shape, skin colour, massiveness of the breast, nipple position, general appearance, visibility of the surgical scar, and overall satisfaction) to evaluate the degree of satisfaction of the patients themselves about the cosmetic results.
Time frame: Baseline and every 12 months until 60 months
Changes in Quality of life (QOL) - General
It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30
Time frame: Baseline and every 12 months until 60 months
Toxicity (acute and late)
Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Baseline and every 12 months until 60 months
Local control
Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast
Time frame: Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years
Changes in Quality of life (QOL) - Breast
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It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-BR23
Time frame: Baseline and every 12 months until 60 months