Status:
RECRUITING
Accelerated Partial Irradiation of the Breast: New Altered Fractionation
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Breast Cancer
Eligibility:
All Genders
40+ years
Brief Summary
The aim of this observational study is to evaluate a dose fractionation scheme for APBI using external radiotherapy with modulated intensity technique (IMRT), with the possible impact on the quality o...
Detailed Description
Breast cancer is the most common tumor among women; although its treatment used to be very aggressive, nowadays is based on the minimum effective treatment. In non-metastatic patients, the therapeuti...
Eligibility Criteria
Inclusion
- ≥ 45 years or 40-44 if there isn´t any other risk factor
- Diagnosed with infiltrating ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) and that have undergone conservative surgery without ganglionar involvement (pN0) of any histological degree except from invasive lobular carcinoma and with a size ≤ 3 cm.
- Disease free margins (R0: \> 2mm).
- Positive and negative estrogen receptor tumors.
Exclusion
- Multicentric and multifocal tumors, except from if it´s focal and the only risk factor.
- Patients must not have undergone a neoadjuvant QT therapy.
- Patients with BRCA positive mutation will be excluded.
- Those patients unable or unsuitable to understand and accept the informed consent.
- Metastasic´s affectation evidence.
- Extensive lymphovascular invasion, except from if the total resulting size of the focus and breast parenchyma addition is ≤ 3cm.
- Breast implants presence in the breast that´s going to be treated.
- Contraindicated radiotherapy treatment due to a diagnosis of cutaneous lupus, pregnancy or scleroderma.
- Inability to fully know the dosimetric data of the APBI plan.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2026
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT04101656
Start Date
October 15 2019
End Date
June 15 2026
Last Update
November 8 2023
Active Locations (1)
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1
Hospital Universitario Virgen Macarena
Seville, Spain, 41009