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

Breast Cancer Clinical Trial

— AXILL-ART  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321653
• Other study ID #: IEO 0953
• Status: Recruiting
• Start date: April 18, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Maria Cristina Leonardi, MD
• Phone: +39 02 94372156
• Email: cristina.leonardi[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arm Lymphedema
• Breast Cancer
• Breast Neoplasms
• Lymphedema
• Radiotherapy Side Effect

Intervention

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

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with arm lymphedema	Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy	1 year
Secondary	Evaluation of cute locoregional toxicity at breast and axilla	During treatment and within 6 months, acute toxicity is assessed by physician using RTOG scale	6 months
Secondary	Evaluation of chronic toxicity at breast and axilla	Chronic toxicity is evaluated according to LENT-SOMA system as from 6 months onward	5 years
Secondary	Disease free survival	Number of patients with an oncological event (local, regional and distant recurrence free survival)	5 years
Secondary	Overall survival	Number of patient alive after 5 years of follow up	5 years
Secondary	Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla	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	5 years