Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Лучевая терапия Ultra-hypofractionated whole breast radiotherapy
  Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week
• Лучевая терапия Standard Radiation
  Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage

Первичные конечные точки

• Locoregional recurrence (LRR) [Срок оценки: 10 years]

Вторичные конечные точки (8)

• Overall survival [Срок оценки: 10 years]
• Disease-free survival [Срок оценки: 10 years]
• Locoregional control [Срок оценки: 10 years]
• Early and late adverse effects in normal tissues [Срок оценки: 10 years]
• Late adverse effects [Срок оценки: 10 years]
• Acute toxicity rate [Срок оценки: 10 years]
• 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) [Срок оценки: Baseline and 3 months, 6 months, 12 months, 2 years, 10 years after treatment end]
• Measurement Satisfaction of Body Image of the participants [Срок оценки: Baseline and 3 months, 6 months, 12 months after radiotherapy and 2 years, 10 years after treatment end]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• IBCC Oncologia — São Paulo

Идентификаторы

NCT: NCT05665920 · 60905722.0.0000.0072

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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