Trial Title:
Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study
NCT ID:
NCT05776147
Condition:
Radiotherapy Side Effect
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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.
Criteria for eligibility:
Study pop:
Women with breast cancer undergoing radiotherapy with extreme hypofractionation.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
ICC - Instituto do Câncer do Ceará
Address:
City:
Fortaleza
Zip:
60.430-230
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Liêvin Matos Rebouças
Email:
Principal Investigator
Facility:
Name:
Hospital Sírio-Libanês DF
Address:
City:
Brasília
Zip:
70.200-730
Country:
Brazil
Status:
Not yet recruiting
Investigator:
Last name:
Gabriela de Siqueira
Email:
Principal Investigator
Facility:
Name:
Hospital Márcio Cunha da Fundação São Francisco Xavier (HMC-FSFX)
Address:
City:
Ipatinga
Zip:
35.160-158
Country:
Brazil
Status:
Not yet recruiting
Investigator:
Last name:
Harley Francisco de Oliveira
Email:
Principal Investigator
Facility:
Name:
Oncominas - Clínica de Oncologia no Sul de Minas
Address:
City:
Pouso Alegre
Zip:
37.554-216
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Priscilla Furtado Souza Pasquinelli
Email:
Principal Investigator
Facility:
Name:
Real Hospital Português de Beneficência em Pernambuco
Address:
City:
Recife
Zip:
50.030-230
Country:
Brazil
Status:
Not yet recruiting
Investigator:
Last name:
Roberta Kramer Guedes Calixto da Silva
Email:
Principal Investigator
Facility:
Name:
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Address:
City:
Ribeirão Preto
Zip:
14.015-010
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Gustavo Viani
Email:
Principal Investigator
Facility:
Name:
Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)
Address:
City:
Rio De Janeiro
Zip:
22.793-080
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Maria Carolina Perdigão
Email:
Principal Investigator
Facility:
Name:
Hospital Sírio-Libanês SP
Address:
City:
São Paulo
Zip:
01.308-050
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Samir Abdallah Hanna
Email:
Principal Investigator
Facility:
Name:
HAOC - Hospital Alemão Oswaldo Cruz
Address:
City:
São Paulo
Zip:
01.323-020
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Rodrigo Morais Hanriot
Email:
Principal Investigator
Facility:
Name:
BP - A Beneficência Portuguesa de São Paulo
Address:
City:
São Paulo
Zip:
01.323-030
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Robson Ferrigno
Email:
Principal Investigator
Facility:
Name:
A.C. Camargo Cancer Center
Address:
City:
São Paulo
Zip:
01.509-001
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Guilherme Rocha Melo Gondim
Email:
Principal Investigator
Start date:
November 9, 2023
Completion date:
October 9, 2024
Lead sponsor:
Agency:
Latin American Cooperative Oncology Group
Agency class:
Other
Source:
Latin American Cooperative Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05776147
