Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes
AXILL-ART: Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes Without Axillary Dissection in Breast Cancer Conservative Surgery: Observational Study
European Institute of Oncology
120 participants
Apr 18, 2019
OBSERVATIONAL
Conditions
Summary
In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative, scheduled for conservative surgery and Sentinel Node Biopsy (SNB), are enrolled in the protocol if they have 1-2 sentinel lymphnodes (SLNs) with macrometastases. SLN status will be checked on definitive sections.
Eligibility
Inclusion Criteria4
- Histological proven invasive breast cancer
- Breast conserving surgery with no axillary dissection
- Tumor dimension no more then 5 cm and no more than 2 positive sentinel node
- \) Negative surgical margin (no tumor cell on ink) 6) Performance Status (PS) \<2 7) Age \>18 8) Written informed consent
Exclusion Criteria9
- Previous thoracic RT
- Mixed connective disorders
- Distant metastases
- Severe lung or cardiac diseases
- Neoadjuvant systemic therapies
- Axillary dissection
- No surgical axillary investigation
- Mastectomy
- Axillary micrometastasis or isolated tumor cell
Interventions
Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed
Locations(1)
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NCT06321653