Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes
Recruiting
Observational Study
Arm LymphedemaBreast CancerRadiotherapy Side Effect
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
120 (estimated)
Sponsor
European Institute of Oncology · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Histological proven invasive breast cancer
2. Breast conserving surgery with no axillary dissection
3. Tumor dimension no more then 5 cm and no more than 2 positive sentinel node
5\) Negative surgical margin (no tumor cell on ink) 6) Performance Status (PS) \<2 7) Age \>18 8…
Inclusion Criteria:
1. Histological proven invasive breast cancer
2. Breast conserving surgery with no axillary dissection
3. Tumor dimension no more then 5 cm and no more than 2 positive sentinel node
5\) Negative surgical margin (no tumor cell on ink) 6) Performance Status (PS) \<2 7) Age \>18 8) Written informed consent
Exclusion Criteria:
1. Previous thoracic RT
2. Mixed connective disorders
3. Distant metastases
4. Severe lung or cardiac diseases
5. Neoadjuvant systemic therapies
6. Axillary dissection
7. No surgical axillary investigation
8. Mastectomy
9. Axillary micrometastasis or isolated tumor cell
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