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

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Laura Voelcker; Phone Number: +55 51 3384 5334; Email: laura.voelcker@lacogcancerresearch.org
• Study Contact Backup: Name: Laura Mendonça Diefenthäeler; Phone Number: +55 51 3384 5334; Email: laura.mendonca@lacogcancerresearch.org

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 22.793-080
    • Recruiting
    • Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)
    • Principal Investigator: Maria Carolina Perdigão
  • São Paulo, Brazil, 01.323-030
    • Recruiting
    • BP - A Beneficencia Portuguesa de São Paulo
    • Principal Investigator: Robson Ferrigno
  • São Paulo, Brazil, 01.308-050
    • Recruiting
    • Hospital Sírio-Libanês SP
    • Principal Investigator: Samir Abdallah Hanna
  • São Paulo, Brazil, 01.323-020
    • Recruiting
    • HAOC - Hospital Alemão Oswaldo Cruz
    • Principal Investigator: Rodrigo Morais Hanriot
  • São Paulo, Brazil, 01.509-001
    • Recruiting
    • A.C. Camargo Câncer Center
    • Principal Investigator: Guilherme Rocha Melo Gondim
  • Ceará
    • Fortaleza, Ceará, Brazil, 60.430-230
      • Recruiting
      • ICC - Instituto do Câncer do Ceará
      • Principal Investigator: Liêvin Matos Rebouças
  • Distrito Federal
    • Brasília, Distrito Federal, Brazil, 70.200-730
      • Not yet recruiting
      • Hospital Sírio-Libanês DF
      • Principal Investigator: Gabriela de Siqueira
  • Minas Gerais
    • Ipatinga, Minas Gerais, Brazil, 35.160-158
      • Not yet recruiting
      • Hospital Márcio Cunha da Fundação São Francisco Xavier (HMC-FSFX)
      • Principal Investigator: Harley Francisco de Oliveira
    • Pouso Alegre, Minas Gerais, Brazil, 37.554-216
      • Recruiting
      • Oncominas - Clínica de Oncologia no Sul de Minas
      • Principal Investigator: Priscilla Furtado Souza Pasquinelli
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50.030-230
      • Not yet recruiting
      • Real Hospital Português de Beneficência em Pernambuco
      • Principal Investigator: Roberta Kramer Guedes Calixto da Silva
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14.015-010
      • Recruiting
      • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
      • Principal Investigator: Gustavo Viani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women with breast cancer undergoing radiotherapy with extreme hypofractionation.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Latin American Cooperative Oncology Group
• Investigators: Principal Investigator: Gustavo Nader Marte, Latin American Cooperative Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: LACOG 0122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No