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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Radiotherapy Side Effect; Arm Lymphedema
• Intervention / Treatment: Radiation: Hypofractionated radiotherapy scheme

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Maria Cristina Leonardi, MD; Phone Number: +39 02 94372156; Email: cristina.leonardi@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Maria Cristina Leonardi; Phone Number: +39 02 94372156

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with invasive breast cancer staged clinically node negative and no more then 5 cm of breast tumor, scheduled for quadrantectomy and SNB, are enrolled in the protocol if they have 1-2 SLNs with macrometastases. SLN status will be checked on definitive sections

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypofractionated radiotherapy; Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed	Radiation: Hypofractionated radiotherapy scheme; Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with arm lymphedema	Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Evaluation of chronic toxicity at breast and axilla	Chronic toxicity is evaluated according to LENT-SOMA system as from 6 months onward	5 years
Disease free survival	Number of patients with an oncological event (local, regional and distant recurrence free survival)	5 years
Overall survival	Number of patient alive after 5 years of follow up	5 years
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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Maria Cristina Leonardi, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: IEO 0953

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No