Clinical trial NCT05665920: Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
Official title: Clinical Trial to Assess the Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Breast Neoplasm
Keywords: Dose splitting
Acute and late toxicity
Locoregional drainage irradiation
Breast neoplasm
Overall survival
Disease-free survival
Locoregional control
Lead sponsor: Instituto Brasileiro de Controle do Cancer
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Information to the patient and signed informed consent;
* Women aged ≥18 years;
* Breast conserving surgery;
* Invasive adenocarcinoma (except classic invasive lobular carcinoma);
* 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;

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Locoregional recurrence (LRR)
timeFrame: 10 years
Secondary outcomes:
measure: Overall survival
timeFrame: 10 years
measure: Disease-free survival
timeFrame: 10 years
measure: Locoregional control
timeFrame: 10 years
measure: Early and late adverse effects in normal tissues
timeFrame: 10 years
measure: Late adverse effects
timeFrame: 10 years
measure: Acute toxicity rate
timeFrame: 10 years
measure: Evaluation of quality of life change by European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
timeFrame: Baseline and 3 months, 6 months, 12 months, 2 years, 10 years after treatment end
measure: Measurement Satisfaction of Body Image of the participants
timeFrame: Baseline and 3 months, 6 months, 12 months after radiotherapy and 2 years, 10 years after treatment end
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: IBCC Oncologia
state: SP
Study officials:
affiliation: IBCC Oncologia
name: Eduardo Barbieri
role: PRINCIPAL_INVESTIGATOR
References: