RecruitingNot ApplicableNCT05665920

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

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


Sponsor

Instituto Brasileiro de Controle do Cancer

Enrollment

36 participants

Start Date

Oct 18, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two radiotherapy schedules for women with early-stage breast cancer who need radiation to the breast and lymph nodes after breast-conserving surgery (lumpectomy). It tests whether a shorter, more intense schedule (ultra-hypofractionation) works just as well as the standard moderate hypofractionation schedule. **You may be eligible if...** - You are a woman aged 18 or older - You had breast-conserving surgery (lumpectomy) for invasive breast cancer - Your cancer stage is T1–T3 and N1–N3a (no distant spread) - Your radiation plan includes treatment of the regional lymph nodes - You are in good health (ECOG 0–1) - Your surgical margins are clear (at least 2 mm) - You have not had prior breast or chest radiation **You may NOT be eligible if...** - You have had previous radiation to the chest or breast area - You are receiving concurrent chemotherapy (trastuzumab or hormone therapy is allowed) - You have an autoimmune or connective tissue disease - You have known genetic repair disorders (e.g., ataxia telangiectasia or Fanconi anemia) - You have metastatic disease - You have a metaplastic carcinoma histology Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONUltra-hypofractionated whole breast radiotherapy

Ultra-hypofractionated whole breast radiotherapy, 26 Gray (26Gy) in 5 fractions for one week

RADIATIONStandard Radiation

Standard Radiation: Whole Breast Irradiation, at 40 Gy, in 15 fractions and drainage


Locations(1)

IBCC Oncologia

São Paulo, São Paulo, Brazil

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NCT05665920


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