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Accelerated Partial Irradiation of the Breast: New Altered Fractionation

RECRUITINGSponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Actively Recruiting
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla
Started2019-10-15
Est. completion2026-05-15
Eligibility
Age40 Years+
Healthy vol.Accepted

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 of life of patients as it decreases the treatment number of sessions and improves the efficiency and accessibility.

Eligibility

Age: 40 Years+Healthy volunteers accepted
Inclusion Criteria:

* ≥ 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 Criteria:

* 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.

Conditions2

Breast CancerCancer

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