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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Radiotherapy (IORT) | Experimental | Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Radiotherapy (IORT) | Radiation | The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes 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) | 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. | Baseline and every 12 months until 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and every 12 months until 60 months |
| Toxicity (acute and late) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evelyn MartÃnez, MD | Contact | +34 93 260 77 20 | emperez@iconcologia.net |
| Name | Affiliation | Role |
|---|---|---|
| Evelyn MartÃnez, MD | Institut Català d'Oncologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evelyn MartÃnez | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
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Intraoperative Radiotherapy (IORT)
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| Breast conservative surgery | Procedure | Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery |
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| External Beam Hypofractionated Radiotherapy (EBRT) | Radiation | 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. |
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Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
| Baseline and every 12 months until 60 months |
| Local control | Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast | Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years |
| Changes in Quality of life (QOL) - Breast | It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-BR23 | Baseline and every 12 months until 60 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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