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

NCT ID: NCT05776147

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-09

Study Completion Date

2025-06-01

Brief Summary

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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

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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.

Conditions

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Radiotherapy Side Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Latin American Cooperative Oncology Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gustavo Nader Marte

Role: PRINCIPAL_INVESTIGATOR

Latin American Cooperative Oncology Group

Locations

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ICC - Instituto do Câncer do Ceará

Fortaleza, Ceará, Brazil

Site Status RECRUITING

Hospital Sírio-Libanês DF

Brasília, Federal District, Brazil

Site Status NOT_YET_RECRUITING

Hospital Márcio Cunha da Fundação São Francisco Xavier (HMC-FSFX)

Ipatinga, Minas Gerais, Brazil

Site Status NOT_YET_RECRUITING

Oncominas - Clínica de Oncologia no Sul de Minas

Pouso Alegre, Minas Gerais, Brazil

Site Status RECRUITING

Real Hospital Português de Beneficência em Pernambuco

Recife, Pernambuco, Brazil

Site Status NOT_YET_RECRUITING

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)

Rio de Janeiro, , Brazil

Site Status RECRUITING

Hospital Sírio-Libanês SP

São Paulo, , Brazil

Site Status RECRUITING

HAOC - Hospital Alemão Oswaldo Cruz

São Paulo, , Brazil

Site Status RECRUITING

BP - A Beneficência Portuguesa de São Paulo

São Paulo, , Brazil

Site Status RECRUITING

A.C. Camargo Cancer Center

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Laura Mendonça Diefenthäeler

Role: CONTACT

+55 51 3384 5334

Laura Voelcker

Role: CONTACT

+55 51 3384 5334

Other Identifiers

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LACOG 0122

Identifier Type: -

Identifier Source: org_study_id

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