Status:
COMPLETED
Adjuvant Partial-breast Irradiation Using Stereotactic Body Radiation Therapy
Lead Sponsor:
Masaryk Memorial Cancer Institute
Conditions:
Early-stage Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
The adjuvant radiotherapy (RT) of the early-stage breast cancer patients as local treatment aims to eliminate the potential microscopic residual disease in the surgery bed or satellites in its neighbo...
Detailed Description
Early-stage breast cancer patients after partial mastectomy are screened for eligibility. The inclusion criteria are age ˃ 50 years, non-lobular carcinoma histology, size ≤ 2 cm, negative margins ≥ 2 ...
Eligibility Criteria
Inclusion
- Patients referred to medical attention for adjuvant radiotherapy of early-stage breast cancer at the Department of Radiation Oncology, Masaryk Memorial Cancer Institute (MMCI) were screened for eligibility. If all inclusion/exclusion criteria will be met, they were invited to participate in the present study.
- Age ≥50 years
- Karnofsky index \> 70
- Partial mastectomy (breast-conserving surgery)
- DCIS G1/2 ≤ 2.5 cm with negative margins (≥ 3 mm) or invasive (non-lobular) luminal-like HER2 negative carcinoma ≤ 2 cm with negative margins (≥ 2 mm) without LVI
- In the case of invasive carcinoma, performing of axillary dissection (≥6 negative lymph nodes) or negative sentinel node biopsy
Exclusion
- Prior to other chest or breast surgery (including breast reconstruction), the absence of surgical clips in the tumor bed
- Prior ipsilateral chest or breast radiotherapy
- Neoadjuvant systemic therapy
- Adjuvant chemotherapy
- Multifocal or multicentric involvement
- BRCA 1 or 2 mutations or known mutations in other high penetrance genes
- Any systemic illness (collagen vascular diseases) or unstable medical condition that might pose additional risks for the performance of radiotherapy including claustrophobia or jactation
- Any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements
- Pregnancy or breastfeeding
- Inability or unwillingness of the subject to sign written informed consent
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06007118
Start Date
May 1 2019
End Date
July 7 2023
Last Update
August 23 2023
Active Locations (1)
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1
Masaryk Memorial Cancer Institute
Brno, Czech Republic, Czechia, 65653