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Clinical Trials/NCT05776147
NCT05776147
Recruiting
Not Applicable

Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study

Latin American Cooperative Oncology Group11 sites in 1 country400 target enrollmentNovember 9, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radiotherapy Side Effect
Sponsor
Latin American Cooperative Oncology Group
Enrollment
400
Locations
11
Primary Endpoint
Locoregional recurrence
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The radiotherapy scheme with extreme hypofractionation has gained space in clinical practice and, therefore, it is necessary to analyze the Brazilian national experience in selected patients with breast cancer, with the aim of evaluating the oncological outcomes and toxicities with the use of this treatment protocol.

Detailed Description

All patients diagnosed with breast cancer who meet the eligibility criteria at participating centers will be included. Data will be collected from medical records at selected centers. Data collection will start from the location activation date. Data from up to 500 patients are expected to be collected at centers across Brazil. Patients recruited for this study will be identified at participating centers. Data on clinical, demographic and socioeconomic variables will be collected, as well as data on treatments performed and outcomes. The patient data sources will be the patients' medical records. Patients will continue to receive treatment and clinical evaluations for their illness as determined by their medical team, in accordance with the standards of care and usual clinical practice at each center. No intervention is proposed in this study.

Registry
clinicaltrials.gov
Start Date
November 9, 2023
End Date
June 1, 2025
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women over 18 years old;
  • Diagnosis of breast cancer of any molecular subtype;
  • Undergoing extreme hypofractionated radiotherapy (5 x 5.2Gy) postoperatively;
  • Treated from December/2019 onward;
  • With clinical and treatment data available in medical records.

Exclusion Criteria

  • The protocol does not provide exclusion criteria.

Outcomes

Primary Outcomes

Locoregional recurrence

Time Frame: 18 months

To evaluate the effectiveness of the extreme hypofractionation scheme, in 5 fractions of 5.2 Gy, in women with breast cancer

Study Sites (11)

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