Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study (RADIANT)
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| ClinicalTrials.gov Identifier: NCT05776147 |
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Recruitment Status :
Recruiting
First Posted : March 20, 2023
Last Update Posted : February 20, 2024
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Sponsor:
Latin American Cooperative Oncology Group
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group
| Tracking Information | |||||||||
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| First Submitted Date | March 8, 2023 | ||||||||
| First Posted Date | March 20, 2023 | ||||||||
| Last Update Posted Date | February 20, 2024 | ||||||||
| Actual Study Start Date | November 9, 2023 | ||||||||
| Estimated Primary Completion Date | October 9, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study | ||||||||
| Official Title | Radiotherapy With Extreme Hypofractionation in Patients With Breast Cancer in Brazil: a Retrospective Cohort Study | ||||||||
| 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. | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Women with breast cancer undergoing radiotherapy with extreme hypofractionation. | ||||||||
| Condition | Radiotherapy Side Effect | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
400 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | October 9, 2024 | ||||||||
| Estimated Primary Completion Date | October 9, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | Brazil | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT05776147 | ||||||||
| Other Study ID Numbers | LACOG 0122 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Latin American Cooperative Oncology Group | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Latin American Cooperative Oncology Group | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Latin American Cooperative Oncology Group | ||||||||
| Verification Date | February 2024 | ||||||||