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

NCT ID: NCT06321653

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-18
• Study Completion Date: 2027-12-31

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).

Conditions

Arm Lymphedema; Breast Cancer; Radiotherapy Side Effect

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hypofractionated radiotherapy

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

Hypofractionated radiotherapy scheme

Intervention Type: RADIATION

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

Interventions

Hypofractionated radiotherapy scheme

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Cristina Leonardi, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria Cristina Leonardi, MD

Role: CONTACT

cristina.leonardi@ieo.it

+39 02 94372156

Facility Contacts

Maria Cristina Leonardi

Role: primary

+39 02 94372156

Other Identifiers

IEO 0953

Identifier Type: -

Identifier Source: org_study_id