Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultra-hypofractionated whole breast radiotherapy, Standard Radiation.
- Who it may be relevant to
- Registry conditions: Malignant Breast Neoplasm. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Radiation Ultra-hypofractionated whole breast radiotherapy
Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week - Radiation Standard Radiation
Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage
Primary outcome measures
- Locoregional recurrence (LRR) [Time frame: 10 years]
Secondary outcome measures (8)
- Overall survival [Time frame: 10 years]
- Disease-free survival [Time frame: 10 years]
- Locoregional control [Time frame: 10 years]
- Early and late adverse effects in normal tissues [Time frame: 10 years]
- Late adverse effects [Time frame: 10 years]
- Acute toxicity rate [Time frame: 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) [Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 10 years after treatment end]
- Measurement Satisfaction of Body Image of the participants [Time frame: Baseline and 3 months, 6 months, 12 months after radiotherapy and 2 years, 10 years after treatment end]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- IBCC Oncologia — São Paulo
Identifiers
NCT: NCT05665920 · 60905722.0.0000.0072