Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypofractionated radiotherapy scheme.
- Who it may be relevant to
- Registry conditions: Arm Lymphedema, Breast Cancer, Radiotherapy Side Effect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
In recent years, breast oncologic surgery has aimed to omit axillary dissection in cases where no more than two sentinel lymph nodes are positive, particularly when complementary radiotherapy to the whole breast is planned.
Radiation therapy to the axillary lymph nodes ensures excellent locoregional control in patients with primary tumor no more than 5 centimeter and 1-2 macrometastatic sentinel lymph nodes, and appears to carry fewer side effects than axillary dissection.
Arm lymphedema is indeed one of the most well-known long-term complications of breast cancer treatment, impacting the quality of life for patients undergoing lymphadenectomy. In this scenario, the study proposes a treatment of hypofractionated intensity-modulated radiotherapy (IMRT) to the breast and axillary lymph nodes with the aim of further containing the risk of developing ipsilateral arm lymphedema. IMRT improves the dosimetric profile of surrounding organs at risk in the treated area, with better dose conformity to the target volume compared to tangential fields used in conventional 3D conformal techniques (as employed in most trials described so far).
Interventions
- Radiation Hypofractionated radiotherapy scheme
Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed
Primary outcome measures
- Percentage of patients with arm lymphedema [Time frame: 1 year]
Secondary outcome measures (5)
- Evaluation of cute locoregional toxicity at breast and axilla [Time frame: 6 months]
- Evaluation of chronic toxicity at breast and axilla [Time frame: 5 years]
- Disease free survival [Time frame: 5 years]
- Overall survival [Time frame: 5 years]
- Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla [Time frame: 5 years]
Eligibility criteria
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
5\) 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- European Institute of Oncology — Milan
Identifiers
NCT: NCT06321653 · IEO 0953