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

NCT06321653 | Recruiting

• 1 other identifier: IEO 0953
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Arm Lymphedema; Breast Cancer; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with arm lymphedema

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

  1 year

Secondary Outcomes (5)

• Evaluation of cute locoregional toxicity at breast and axilla

  6 months

• Evaluation of chronic toxicity at breast and axilla

  5 years

• Disease free survival

  5 years

• Overall survival

  5 years

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

  5 years

Study Arms (1)

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

Interventions

Hypofractionated radiotherapy scheme RADIATION

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

Hypofractionated radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Maria Cristina Leonardi, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cristina Leonardi, MD

CONTACT

+39 02 94372156; cristina.leonardi@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: April 18, 2019
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

IT (1)