Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes
Recruiting · NCT06321653 · Observational (researchers observe without assigning treatment) · Lead sponsor: European Institute of Oncology
View the official record on ClinicalTrials.gov →Interventions studied
Hypofractionated radiotherapy scheme
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- European Institute of Oncology - Milan, Italy