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NCT Number: NCT06321653

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

European Institute of Oncology

Milan, Italy

Location status: Recruiting

Location contact

Maria Cristina Leonardi

CONTACT

+39 02 94372156

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Hypofractionated radiotherapy scheme

Radiation

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

Primary outcomes

  1. Percentage of patients with arm lymphedema

    Time frame: 1 year

    Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy

Secondary outcomes

  1. Evaluation of cute locoregional toxicity at breast and axilla

    Time frame: 6 months

    During treatment and within 6 months, acute toxicity is assessed by physician using RTOG scale

  2. Evaluation of chronic toxicity at breast and axilla

    Time frame: 5 years

    Chronic toxicity is evaluated according to LENT-SOMA system as from 6 months onward

  3. Disease free survival

    Time frame: 5 years

    Number of patients with an oncological event (local, regional and distant recurrence free survival)

  4. Overall survival

    Time frame: 5 years

    Number of patient alive after 5 years of follow up

  5. Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Cristina Leonardi, MD

CONTACT

[email protected]

+39 02 94372156

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study 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

Acronym: AXILL-ART

Important dates

Study start
2019
Primary completion
2024
Study completion
2027
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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