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

Radiotherapy Side Effect Clinical Trial

— RADIANT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776147
• Other study ID #: LACOG 0122
• Status: Recruiting
• Start date: November 9, 2023
• Est. completion date: October 9, 2024

Study information

• Verified date: February 2024
• Source: Latin American Cooperative Oncology Group
• Contact: Laura Mendonça Diefenthäeler
• Phone: +55 51 3384 5334
• Email: laura.mendonca[@]lacogcancerresearch.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 9, 2024
• Est. primary completion date: October 9, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 to December/2021;
• With clinical and treatment data available in medical records.

Exclusion Criteria:

• The protocol does not provide exclusion criteria.

Related Conditions & MeSH terms

• Radiotherapy Side Effect

Locations

Country	Name	City	State
Brazil	Hospital Sírio-Libanês DF	Brasília	Distrito Federal
Brazil	ICC - Instituto do Câncer do Ceará	Fortaleza	Ceará
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	A.C. Camargo Cancer Center	São Paulo
Brazil	BP - A Beneficência Portuguesa de São Paulo	São Paulo
Brazil	HAOC - Hospital Alemão Oswaldo Cruz	São Paulo
Brazil	Hospital Sírio-Libanês SP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional recurrence	To evaluate the effectiveness of the extreme hypofractionation scheme, in 5 fractions of 5.2 Gy, in women with breast cancer	18 months