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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05776147
Recruitment Status : Recruiting
First Posted : March 20, 2023
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

Study Description
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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.

Condition or disease
Radiotherapy Side Effect

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study
Actual Study Start Date : November 9, 2023
Estimated Primary Completion Date : October 9, 2024
Estimated Study Completion Date : October 9, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Locoregional recurrence [ Time Frame: 18 months ]
    To evaluate the effectiveness of the extreme hypofractionation scheme, in 5 fractions of 5.2 Gy, in women with breast cancer


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Women with breast cancer undergoing radiotherapy with extreme hypofractionation.
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 to December/2021;
  • With clinical and treatment data available in medical records.

Exclusion Criteria:

  • The protocol does not provide exclusion criteria.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05776147


Contacts
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Contact: Laura Mendonça Diefenthäeler +55 51 3384 5334 laura.mendonca@lacogcancerresearch.org
Contact: Laura Voelcker +55 51 3384 5334 laura.voelcker@lacogcancerresearch.org

Locations
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Brazil
ICC - Instituto do Câncer do Ceará Recruiting
Fortaleza, Ceará, Brazil, 60.430-230
Principal Investigator: Liêvin Matos Rebouças         
Hospital Sírio-Libanês DF Not yet recruiting
Brasília, Distrito Federal, Brazil, 70.200-730
Principal Investigator: Gabriela de Siqueira         
Hospital Márcio Cunha da Fundação São Francisco Xavier (HMC-FSFX) Not yet recruiting
Ipatinga, Minas Gerais, Brazil, 35.160-158
Principal Investigator: Harley Francisco de Oliveira         
Oncominas - Clínica de Oncologia no Sul de Minas Recruiting
Pouso Alegre, Minas Gerais, Brazil, 37.554-216
Principal Investigator: Priscilla Furtado Souza Pasquinelli         
Real Hospital Português de Beneficência em Pernambuco Not yet recruiting
Recife, Pernambuco, Brazil, 50.030-230
Principal Investigator: Roberta Kramer Guedes Calixto da Silva         
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP Recruiting
Ribeirão Preto, São Paulo, Brazil, 14.015-010
Principal Investigator: Gustavo Viani         
Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ) Recruiting
Rio De Janeiro, Brazil, 22.793-080
Principal Investigator: Maria Carolina Perdigão         
Hospital Sírio-Libanês SP Recruiting
São Paulo, Brazil, 01.308-050
Principal Investigator: Samir Abdallah Hanna         
HAOC - Hospital Alemão Oswaldo Cruz Recruiting
São Paulo, Brazil, 01.323-020
Principal Investigator: Rodrigo Morais Hanriot         
BP - A Beneficência Portuguesa de São Paulo Recruiting
São Paulo, Brazil, 01.323-030
Principal Investigator: Robson Ferrigno         
A.C. Camargo Cancer Center Recruiting
São Paulo, Brazil, 01.509-001
Principal Investigator: Guilherme Rocha Melo Gondim         
Sponsors and Collaborators
Latin American Cooperative Oncology Group
Investigators
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Principal Investigator: Gustavo Nader Marte Latin American Cooperative Oncology Group
More Information
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Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT05776147    
Other Study ID Numbers: LACOG 0122
First Posted: March 20, 2023    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No