Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
This is a prospective, interventional, exploratory, controlled, randomized study in a 1:1 ratio, to be carried out in a single center, and seeks to evaluate the safety and efficacy of hypofractionated irradiation in women with breast cancer who receive nodal irradiation regional.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Information to the patient and signed informed consent;
TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol;
Eastern Cooperative Oncology Group (ECOG) 0 -1;
Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia);
No previous breast or mediastinal radiotherapy;
No hematogenous metastases;
Ability to carry out long-term follow-up;
You may not be if
Previous local irradiation;
Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed;
Histology of metaplastic carcinoma;
History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed.
Diagnosis of autoimmune and connective tissue diseases;
Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia);
Indication of internal breast irradiation.
Clareo Health | Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
