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Recruiting NCT05776147

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

Observational Radiotherapy Side Effect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Radiotherapy Side Effect. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Locoregional recurrence [Time frame: 18 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Brazil · 11 centers
  • ICC - Instituto do Câncer do Ceará — Fortaleza
  • Hospital Sírio-Libanês DF — Brasília
  • Hospital Márcio Cunha da Fundação São Francisco Xavier (HMC-FSFX) — Ipatinga
  • Oncominas - Clínica de Oncologia no Sul de Minas — Pouso Alegre
  • Real Hospital Português de Beneficência em Pernambuco — Recife
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP — Ribeirão Preto
  • Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ) — Rio de Janeiro
  • Hospital Sírio-Libanês SP — São Paulo
  • … and 3 more centers

Identifiers

NCT: NCT05776147 · LACOG 0122

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗