NCT05665920

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Instituto Brasileiro de Controle do Cancer · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Malignant Breast Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-18
• Primary completion: 2027-10-18
• Completion: 2030-12-31
• First posted: 2022-12-27
• Last updated: 2022-12-29

Locations

1 site across 1 country: Brazil