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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05776147
Other study ID # LACOG 0122
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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