Actively Recruiting
Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
Led by Instituto Brasileiro de Controle do Cancer · Updated on 2022-12-29
36
Participants Needed
1
Research Sites
428 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and patient information provided
- Women aged 18 years or older
- Breast conserving surgery performed
- Diagnosis of invasive adenocarcinoma (excluding classic invasive lobular carcinoma)
- Pathologic TNM stage pT1-3 and pN1-3a M0 with indication for lymphatic drainage
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in deep fascia)
- No previous breast or mediastinal radiotherapy
- No hematogenous metastases
- Ability to undergo long-term follow-up
You will not qualify if you...
- Previous local irradiation
- Receiving concomitant chemotherapy (trastuzumab or hormone blockade allowed)
- Histology of metaplastic carcinoma
- History of another neoplasm except non-melanoma skin cancer or carcinoma in situ of the uterine cervix; other neoplasms allowed if treated with curative intent and no evidence of disease for 5 years
- Diagnosis of autoimmune or connective tissue diseases
- Diagnosis of genetic alterations in cell repair genes (e.g., Fanconi anemia, ataxia telangiectasia)
- Indication for internal breast irradiation
AI-Screening
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Trial Site Locations
Total: 1 location
1
IBCC Oncologia
São Paulo, São Paulo, Brazil, 03102-002
Actively Recruiting
Research Team
E
Eduardo Barbieri
CONTACT
A
Alayne Yamada, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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