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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of patients with arm lymphedema
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Previous thoracic RT
- •Mixed connective disorders
- •Distant metastases
- •Severe lung or cardiac diseases
- •Neoadjuvant systemic therapies
- •Axillary dissection
- •No surgical axillary investigation
- •Axillary micrometastasis or isolated tumor cell
结局指标
主要结局
Percentage of patients with arm lymphedema
时间窗: 1 year
Incidence of ipsilateral arm lymphedema 1 year after the completion of adjuvant radiotherapy
次要结局
- Evaluation of chronic toxicity at breast and axilla(5 years)
- Evaluation of cute locoregional toxicity at breast and axilla(6 months)
- 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)