Arm Lymphedema, Breast Cancer, Radiotherapy Side Effect
Conditions
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).
Interventions
RADIATIONHypofractionated radiotherapy scheme
Hypofractionated radiotherapy scheme with 2.67Gy/fraction for 15 fractions. WBRT with simultaneous integrated boost to the tumor bed
Sponsors
European Institute of Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with arm lymphedema | 1 year | Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of cute locoregional toxicity at breast and axilla | 6 months | During treatment and within 6 months, acute toxicity is assessed by physician using RTOG scale |
| Evaluation of chronic toxicity at breast and axilla | 5 years | Chronic toxicity is evaluated according to LENT-SOMA system as from 6 months onward |
| Disease free survival | 5 years | Number of patients with an oncological event (local, regional and distant recurrence free survival) |
| Overall survival | 5 years | Number of patient alive after 5 years of follow up |
| Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla | 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 |
Countries
Italy
Contacts
Primary ContactMaria Cristina Leonardi, MD
Outcome results
None listed