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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstituto Brasileiro de Controle do Cancer

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Information to the patient and signed informed consent;

Women aged ≥18 years;

Breast conserving surgery;

Invasive adenocarcinoma (except classic invasive lobular carcinoma);

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultra-hypofractionated whole breast radiotherapy

    Radiation

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

  • Standard Radiation

    Radiation

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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Standard Whole breast RadiotherapyActive comparator 1 intervention
Group B: Ultra-hypofractionated whole breast radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Locoregional recurrence (LRR)

To estimate and compare the rate of local recurrence between the experimental and control arms.

Time frame
10 years

Secondary outcomes

1

Overall survival

Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.

Time frame
10 years
2

Disease-free survival

Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.

Time frame
10 years
3

Locoregional control

Locoregional control defined as biopsy-proven recurrence of breast cancer involving the chest wall, breast, axilla, internal breast or supraclavicular nodes.

Time frame
10 years
4

Early and late adverse effects in normal tissues

To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.

Time frame
10 years

Other outcomes

Sponsors and contacts

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