Multicenter Randomized Pivotal Stage Clinical Investigation Assessing the Communication of an Individualized AI-based Risk Prediction of Arm Lymphedema to Breast Cancer Patients With an Indication for Regional Lymph Node Irradiation and Their Physician as Part of Treatment Shared-decision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UNICANCER
- 入组人数
- 724
- 试验地点
- 28
- 主要终点
- Arm lymphedema
研究概览
简要总结
Radiotherapy after breast cancer surgery can lead to side effects like arm lymphedema (arm swelling). Lymphedema can cause long-term discomfort and affect quality of life.
The goal of this clinical investigation is to determine whether using an artificial intelligence (AI) tool to predict the risk of developing arm lymphedema after breast cancer radiotherapy can help patients and physicians make better treatment decisions.
This AI tool has been developed to determine each patient's personalized risk of developing lymphedema. The risk is shown using a web app that explains the factors involved and offers suggestions like using a compression sleeve to reduce the risk.
Women (≥18 years) with breast cancer (cT1-4, cN0-N3, M0) requiring regional lymph node irradiation post-mastectomy or breast-conserving surgery are eligible, regardless of hormone receptor status, tumor grade, or HER2 status.
Patients will be randomly divided into two groups:
- Experimental group: Patients and physicians will see the AI-predicted risk and use it to guide treatment choices.
- Control group: The risk is not shown.
The radiotherapy treatment will be exactly the same as the treatment that you would have received if you had not taken part in this clinical investigation. The only intervention will be whether or not the risk you are informed of the risk of developing lymphedema.
All patients will be followed for two years to monitor:
- How risk communication influences radiotherapy treatment choices
- The occurrence of side effects
- The predictive performance of the AI tool
- Patients' quality of life
- Compliance with compression sleeve use
- Loco-regional recurrence-free survival, distant disease-free survival, and overall survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient must have signed a written informed consent form prior to inclusion visit and to any study specific procedures
- •Women ≥ 18 years
- •Patients with unilateral invasive breast cancer, cT1-4, cN0-N3, M0 who had undergone radical surgery defined as mastectomy or breast conservation surgery with negative margins +/- (neo)-adjuvant systemic treatment. The patient can be included no matter the status of estrogen and progesterone receptors, malignancy grade, and HER2 status
- •Axillary lymph node staging (by axillary dissection or sentinel lymph node biopsy and/or marked lymph node biopsy [Marking Axillary lymph nodes with Radioactive Iodine seeds (MARI) procedure/ (Targeted Axillary Dissection (TAD) procedure] in case of neo-adjuvant systemic treatment) defining the indication for regional nodal irradiation to levels I+/- II+/- III+/- IV+/- interpectoral nodes (Rotter) +/- the IMC(Internal Mammary Chain)
- •ECOG performance status 0-2
- •Patient must be randomized within the recommended time period from last surgery or the last series of chemotherapy whichever comes last as per national or institutional guidelines in order not to delay radiotherapy treatment start
- •Women of childbearing potential must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of radiotherapy
- •Patient is willing and able to comply with the protocol for the duration of the clinical investigation including undergoing treatment and scheduled visits, and examinations including follow-up
- •Patient affiliated to or a beneficiary of the local social security system, health service or other local regulatory requirements
排除标准
- •Previous breast cancer or Ductal Carcinoma in Situ (DCIS) of the ipsilateral breast
- •Bilateral breast cancer
- •Patient with previous non-breast malignancy, with the exception of cancer in complete remission for over 5 years and low risk of recurrence. Patients with the following diseases can be accepted despite less than 5 years disease free interval: carcinoma in situ of the cervix, melanoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- •Patient who has an indication for boost to one or more regional nodes
- •Previous radiation therapy to the chest region
- •Patients having arm swelling requiring arm sleeve prescription at baseline
- •Any condition that prevents the patient from wearing a compression sleeve for 8h/day from the first day of radiation therapy until 3 months after the initiation of adjuvant radiotherapy
- •Pregnant or breastfeeding women
- •Patient already included in another therapeutic study involving radiotherapy dose/regimen/technique and/or arm lymphedema risk
- •Person deprived of their liberty or under protective custody or guardianship
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究组 & 干预措施
Communication of the AI-based risk prediction to patient and physician.
干预措施: XAINET AI tool (Device)
No communication of the AI-based risk prediction to patient and physician.
结局指标
主要结局
Arm lymphedema
时间窗: At 2 years
Cumulative incidence of arm lymphedema on the treated side 2 years after adjuvant radiotherapy. The definition of arm lymphedema is ≥5% increased arm circumference measured 15 cm proximal and/or 10 cm distal of the olecranon of the treated side from baseline, compared to the contralateral side circumference and to its baseline value
次要结局
- Impact of communicating the risk prediction for arm lymphedema on the choice of radiotherapy modality, fractionation, technique and nodal levels irradiated(Up to 3 months from randomization.)
- Acute and late toxicity during the study(Throughout study completion, up to 2 years.)
- Range of shoulder motion (ROM) of the arms(Throughout study completion, up to 2 years.)
- Breast cosmetic result(Throughout study completion, up to 2 years.)
- Performance of the arm lymphedema risk prediction model(At 2 years)
- Quality of life questionnaire - Core 30 (QLQ-C30)(At baseline, end of treatment visit, 1 year and 2 years)
- Quality of Life Questionnaire - Breast cancer module (QLQ-BR23)(At baseline, end of treatment visit, 1 year and 2 years)
- The Developed 5-level version of EQ-5D (EQ-5D-5L) questionnaire(At baseline, end of treatment visit, 1 year and 2 years)
- Compliance with compression arm sleeve use(At end of treatment visit, 3-month after starting radiotherapy, at 1 year and 2 years)
- Loco-regional relapse-free survival (RFS)(From randomization until the first invasive ipsilateral breast tumor recurrence, loco regional invasive recurrence, ipsilateral DCIS or death from any cause up to 2 years)
- Distant disease-free survival (DDFS)(From randomization until the recurrence of disease or death from any cause up to 2 years)
- Overall survival (OS)(From randomization to death from any cause, up to 2 years)