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Clinical Trials in Italy / NCT06321653
Recruiting Observational

Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes

NCT06321653 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Observational
Started
2019-04-18
Last updated
2024-03-20

Condition(s) studied

Arm LymphedemaBreast CancerRadiotherapy Side Effect

Investigational drug(s) / intervention(s)

Hypofractionated radiotherapy scheme

Hypofractionated radiotherapy scheme: Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percentage of patients with arm lymphedema — 1 year
    Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy Recruiting

More European Institute of Oncology trials in Italy

MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer Recruiting
YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs. Recruiting
A New Tool to Promote Patient's Engagement in Their Healthcare Process Recruiting
Cognitive Impairment Assessment in Breast Cancer Survivors Starting soon
Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site Recruiting

Other trials for the same condition

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) Active, not recruiting
The OPBC-07/microNAC Study Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study Active, not recruiting
Music Therapy in Patients With Breast Cancer (IMPACT) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06321653 on ClinicalTrials.gov ↗ ← All trials in Italy