Clinical trial NCT05776147: Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study
Official title: Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiotherapy Side Effect
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with breast cancer undergoing radiotherapy with extreme hypofractionation.

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.

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.

Primary outcomes:
measure: Locoregional recurrence
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: ICC - Instituto do Câncer do Ceará
state: Ceará
city: Brasília
country: Brazil
facility: Hospital Sírio-Libanês DF
state: Distrito Federal
city: Ipatinga
country: Brazil
facility: Hospital Márcio Cunha da Fundação São Francisco Xavier (HMC-FSFX)
state: Minas Gerais
city: Pouso Alegre
country: Brazil
facility: Oncominas - Clínica de Oncologia no Sul de Minas
state: Minas Gerais
city: Recife
country: Brazil
facility: Real Hospital Português de Beneficência em Pernambuco
state: Pernambuco
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)
city: São Paulo
country: Brazil
facility: Hospital Sírio-Libanês SP
city: São Paulo
country: Brazil
facility: HAOC - Hospital Alemão Oswaldo Cruz
city: São Paulo
country: Brazil
facility: BP - A Beneficência Portuguesa de São Paulo
city: São Paulo
country: Brazil
facility: A.C. Camargo Cancer Center
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Nader Marte
role: PRINCIPAL_INVESTIGATOR
References: