Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for Breast Cancer
NCT ID: NCT05850637
Last Updated: 2024-04-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-01-30
Study Completion Date
2023-04-01
Brief Summary
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Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.
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Detailed Description
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Prospective phase 2 non-randomized single-arm study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.
Conditions
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Breast Cancer Female
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Prospective phase 2 non-randomized single-arm study
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Single Arm Ultra-hypofractionated
5 fractions of 5.7 Gy every other day in the breast or chest wall region, with or without the inclusion of regional lymph node drainage chains
Group Type
EXPERIMENTAL
adjuvant ultra-hypofractionated radiotherapy
Intervention Type
RADIATION
adjuvant ultra-hypofractionated radiotherapy for the treatment of early and locally advanced breast cancer
Interventions
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adjuvant ultra-hypofractionated radiotherapy
adjuvant ultra-hypofractionated radiotherapy for the treatment of early and locally advanced breast cancer
Intervention Type
RADIATION
Eligibility Criteria
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Inclusion Criteria
1. Female patient;
2. Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile;
3. Age greater than or equal to 65 years;
4. Breast-conserving surgery or mastectomy with or without axillary approach
5. With or without neoadjuvant or adjuvant systemic treatment
2. Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile;
3. Age greater than or equal to 65 years;
4. Breast-conserving surgery or mastectomy with or without axillary approach
5. With or without neoadjuvant or adjuvant systemic treatment
Exclusion Criteria
1. Patients with previous thoracic irradiation;
2. Patients with indication for bilateral thoracic irradiation;
3. Patients with breast reconstruction with prosthesis or autologous tissue;
4. Patients with compromised surgical margins after resection;
5. pT1-pT2 pN0 patients undergoing radical mastectomy.
2. Patients with indication for bilateral thoracic irradiation;
3. Patients with breast reconstruction with prosthesis or autologous tissue;
4. Patients with compromised surgical margins after resection;
5. pT1-pT2 pN0 patients undergoing radical mastectomy.
Minimum Eligible Age
65 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Prevent Senior Institute
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Marcel MF Fang, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Pesquisa Prevent Senior
Locations
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Instituto de Pesquisa Prevent Senior
São Paulo, , Brazil
Site Status
Countries
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Brazil
References
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Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INSTITUTO PREVENT SENIOR - IPS
Identifier Type: -
Identifier Source: org_study_id
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