Radiotherapy Side EffectRADIANTNCT05776147
Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study
An observational study of Radiotherapy Side Effect, run by Latin American Cooperative Oncology Group at 11 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiotherapy Side Effect
- How many people
- 461 participants
- Where
- 11 sitesBrazil
- Study dates
- 9 Nov 2023to 2 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Women with breast cancer undergoing radiotherapy with extreme hypofractionation.
Who may be able to join
- 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.
Who cannot join
- The protocol does not provide exclusion criteria.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Brazil11 sites
Hospital Sírio-Libanês DF
Brasília, Federal District, 70.200-730
ICC - Instituto do Câncer do Ceará
Fortaleza, Ceará, 60.430-230
Hospital Márcio Cunha da Fundação São Francisco Xavier (HMC-FSFX)
Ipatinga, Minas Gerais, 35.160-158
Oncominas - Clínica de Oncologia no Sul de Minas
Pouso Alegre, Minas Gerais, 37.554-216
Real Hospital Português de Beneficência em Pernambuco
Recife, Pernambuco, 50.030-230
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, 14.015-010
Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)
Rio de Janeiro, Rio de Janeiro, 22.793-080
Hospital Sírio-Libanês SP
São Paulo, São Paulo, 01.308-050
HAOC - Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, 01.323-020
BP - A Beneficência Portuguesa de São Paulo
São Paulo, São Paulo, 01.323-030
A.C. Camargo Cancer Center
São Paulo, São Paulo, 01.509-001
About this study
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.
Read the 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.
- Conditions
- Radiotherapy Side Effect
- Medical subject headings
- Radiation Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional recurrence
To evaluate the effectiveness of the extreme hypofractionation scheme, in 5 fractions of 5.2 Gy, in women with breast cancer
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start9 Nov 2023
- Primary completion2 Sep 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Side EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gustavo Nader Marte, Principal investigator, Latin American Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776147
- Sponsor's protocol ID
- LACOG 0122
- Acronym
- RADIANT
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05776147
- Acronym / sponsor ID
- RADIANT / LACOG 0122
- Conditions
- Radiotherapy Side Effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with breast cancer undergoing radiotherapy with extreme hypofractionation.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- The protocol does not provide exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Nader Marte principal investigator
Latin American Cooperative Oncology Group
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy Side Effect, run by Latin American Cooperative Oncology Group at 11 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional recurrence (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.