About this trial
The reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. Thus, as a reference Institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 Gy / 5 fractions in one week, in a controlled manner, through this project.The investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Information to the patient and signed informed consent;
Women aged ≥18 years;
Breast conserving surgery;
Invasive adenocarcinoma (except classic invasive lobular carcinoma);
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Ultra-hypofractionated whole breast radiotherapy
RadiationUltra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week
Standard Radiation
RadiationStandard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage
Treatment groups
Trial outcomes
Primary outcomes
Locoregional recurrence (LRR)
To estimate and compare the rate of local recurrence between the experimental and control arms.
Secondary outcomes
Overall survival
Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.
Disease-free survival
Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.
Locoregional control
Locoregional control defined as biopsy-proven recurrence of breast cancer involving the chest wall, breast, axilla, internal breast or supraclavicular nodes.
Early and late adverse effects in normal tissues
To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
Sponsors and contacts
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