Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arm Lymphedema | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated radiotherapy scheme | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Hypofractionated radiotherapy
- description
- Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed
- interventionNames
- Radiation: Hypofractionated radiotherapy scheme
Primary outcomes (1)
- measure
- Percentage of patients with arm lymphedema
- timeFrame
- 1 year
- description
- Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy
Secondary outcomes (5)
- measure
- Evaluation of cute locoregional toxicity at breast and axilla
- timeFrame
- 6 months
- description
- During treatment and within 6 months, acute toxicity is assessed by physician using RTOG scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available