Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes (AXILL-ART)

European Institute of Oncology

Status: Enrolling

Conditions: Radiotherapy Side Effect; Breast Cancer; Arm Lymphedema

Treatments: Radiation: Hypofractionated radiotherapy scheme

Study type: Observational

Funder types: Other

Identifiers

NCT06321653

IEO 0953

Details and patient eligibility

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

Hypofractionated radiotherapy

Description:

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

Treatment:

Radiation: Hypofractionated radiotherapy scheme