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

Recruiting

• Conditions: Arm Lymphedema; Breast Cancer; Radiotherapy Side Effect
• Interventions: Radiation: Hypofractionated radiotherapy scheme

• Registration Number: NCT06321653
• Lead Sponsor: European Institute of Oncology

Brief 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.

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).

Study Timeline

• Study Start: 2019-04-18
• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypofractionated radiotherapy	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

Name	Time	Method
Percentage of patients with arm lymphedema	1 year	Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy

Secondary Outcome Measures

Name	Time	Method
Disease free survival	5 years	Number of patients with an oncological event (local, regional and distant recurrence free survival)
Evaluation of chronic toxicity at breast and axilla	5 years	Chronic toxicity is evaluated according to LENT-SOMA system as from 6 months onward
Evaluation of cute locoregional toxicity at breast and axilla	6 months	During treatment and within 6 months, acute toxicity is assessed by physician using RTOG scale
Overall survival	5 years	Number of patient alive after 5 years of follow up
Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla	5 years	Numeric Rating Scale (NRS) (NRS-11) is an 11-point scale for patient self-reporting of pain. It is used for rating symptoms like pain, itching and burning

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy