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

Recruiting

• Conditions: Radiotherapy Side Effect

• Registration Number: NCT05776147
• Lead Sponsor: Latin American Cooperative Oncology Group

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.

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-20
• Study Start: 2023-11-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Locoregional recurrence	18 months	To evaluate the effectiveness of the extreme hypofractionation scheme, in 5 fractions of 5.2 Gy, in women with breast cancer

Trial Locations

Locations (11)

ICC - Instituto do Câncer do Ceará; 🇧🇷 Fortaleza, Ceará, Brazil

Hospital Sírio-Libanês DF; 🇧🇷 Brasília, Distrito Federal, Brazil

Hospital Márcio Cunha da Fundação São Francisco Xavier (HMC-FSFX); 🇧🇷 Ipatinga, Minas Gerais, Brazil

Oncominas - Clínica de Oncologia no Sul de Minas; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil

Real Hospital Português de Beneficência em Pernambuco; 🇧🇷 Recife, Pernambuco, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP; 🇧🇷 Ribeirão Preto, São Paulo, Brazil

Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ); 🇧🇷 Rio De Janeiro, Brazil

Hospital Sírio-Libanês SP; 🇧🇷 São Paulo, Brazil

HAOC - Hospital Alemão Oswaldo Cruz; 🇧🇷 São Paulo, Brazil

BP - A Beneficência Portuguesa de São Paulo; 🇧🇷 São Paulo, Brazil

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