Actively Recruiting
Accelerated Partial Irradiation of the Breast: New Altered Fractionation
Led by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Updated on 2023-11-08
174
Participants Needed
1
Research Sites
347 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this observational study is to evaluate a dose fractionation scheme for APBI using external radiotherapy with modulated intensity technique (IMRT), with the possible impact on the quality of life of patients as it decreases the treatment number of sessions and improves the efficiency and accessibility.
CONDITIONS
Official Title
Accelerated Partial Irradiation of the Breast: New Altered Fractionation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 45 years or older, or 40-44 years old without any other risk factors
- Diagnosed with infiltrating ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) after conservative surgery
- No lymph node involvement (pN0) of any histological degree except invasive lobular carcinoma
- Tumor size 3 cm or smaller
- Disease-free margins at least 2 mm (R0)
- Estrogen receptor positive or negative tumors
You will not qualify if you...
- Multicentric and multifocal tumors, unless focal and the only risk factor
- Prior neoadjuvant chemotherapy (QT therapy)
- Positive BRCA mutation
- Unable or unsuitable to understand and accept informed consent
- Evidence of metastatic disease
- Extensive lymphovascular invasion unless total focus and breast tissue size is 3 cm or smaller
- Presence of breast implants in the treated breast
- Contraindications for radiotherapy due to cutaneous lupus, pregnancy, or scleroderma
- Inability to fully know dosimetric data of the APBI plan
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
Research Team
C
Carlos Míguez Sánchez
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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