Evaluating extreme hypofractionated radiotherapy outcomes in Brazilian breast cancer patients

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

This study looks at how well a specific type of radiation therapy works and its side effects in Brazilian women with breast cancer after surgery.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Latin American Cooperative Oncology Group (Academic / other)
• Locations: 11 sites (Fortaleza, Ceará and 10 other locations)
• Trial ID: NCT05776147 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze the outcomes and side effects of extreme hypofractionated radiotherapy in women diagnosed with breast cancer across various centers in Brazil. By collecting data from medical records of up to 500 patients treated postoperatively with a specific radiotherapy regimen, the study seeks to assess both oncological results and treatment-related toxicities. The data collection will focus on clinical, demographic, and socioeconomic variables to provide a comprehensive overview of the treatment's effectiveness and safety in the Brazilian context.

Who should consider this trial

Good fit: Ideal candidates for this study are women over 18 years old diagnosed with any molecular subtype of breast cancer who have undergone extreme hypofractionated radiotherapy postoperatively since December 2019.

Not a fit: Patients who do not meet the age or diagnosis criteria, or those who have not received the specified radiotherapy regimen, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of extreme hypofractionated radiotherapy for breast cancer patients, potentially improving treatment protocols.

How similar studies have performed: While the approach of extreme hypofractionation is gaining traction, this specific analysis of Brazilian patient outcomes is novel and has not been extensively tested in similar cohorts.

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.

Where this trial is running

Fortaleza, Ceará and 10 other locations

• ICC - Instituto do Câncer do Ceará — Fortaleza, Ceará, Brazil (Recruiting)
• Hospital Sírio-Libanês DF — Brasília, Federal District, Brazil (Not_yet_recruiting)
• Hospital Márcio Cunha da Fundação São Francisco Xavier (HMC-FSFX) — Ipatinga, Minas Gerais, Brazil (Not_yet_recruiting)
• Oncominas - Clínica de Oncologia no Sul de Minas — Pouso Alegre, Minas Gerais, Brazil (Recruiting)
• Real Hospital Português de Beneficência em Pernambuco — Recife, Pernambuco, Brazil (Not_yet_recruiting)
• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP — Ribeirão Preto, São Paulo, Brazil (Recruiting)
• Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ) — Rio de Janeiro, Brazil (Recruiting)
• Hospital Sírio-Libanês SP — São Paulo, Brazil (Recruiting)
• HAOC - Hospital Alemão Oswaldo Cruz — São Paulo, Brazil (Recruiting)
• BP - A Beneficência Portuguesa de São Paulo — São Paulo, Brazil (Recruiting)
• A.C. Camargo Cancer Center — São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Gustavo Nader Marte — Latin American Cooperative Oncology Group
• Study coordinator: Laura Mendonça Diefenthäeler

Conditions Radiotherapy Side Effect