NCT06224244进行中（未招募）2 期
A Prospective Phase II Trial of an Accelerated Hypofractionated Radiotherapy Schedule With Risk-adapted Simultaneous Integrated Boost (HF-SIB) in Early Breast Cancer Patients Undergoing Breast Conserving Surgery
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale
研究概览
简要总结
This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer
详细描述
Patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Histologically proven invasive or in situ unifocal adenocarcinoma of the breast
- •Breast conserving surgery
- •Pathological pTis G3, pT1-2 any Grade, pN0 or pN0(sn) (isolated tumor cells [i+] allowed) pN1mic, M0 stage
- •Postoperative negative (no ink) final surgical margins
- •Patient requires a whole breast radiotherapy plus a tumor bed boost
- •Female patients aged ≥ 18 years of any menopausal status
- •ECOG performance status 0-2
排除标准
- •Past history of malignancy except basal cell skin cancer and CIN cervix uteri or non-breast malignancy allowed if treated with curative intent and at least 5 years' disease free
- •Mastectomy
- •Concomitant chemotherapy (primary or sequential chemotherapy allowed) (Chemotherapy and radiotherapy must be separated by a minimum of 2 weeks). (Patients receiving neo-adjuvant chemotherapy are not excluded)
- •Known disorders associated with a higher risk for complications following radiotherapy such as collagen vascular disease, dermatomyositis, systemic lupus erythematosus or scleroderma
- •Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Any serious uncontrolled medical disorder, non-malignant systemic disease, or active uncontrolled infection. Example include but are not limited to uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction or uncontrolled major seizure disorder
- •Pregnant or lactating patients
- •Presence of ipsilateral breast implant
- •Prior breast or thoracic radiotherapy for any condition
结局指标
主要结局
Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scale
时间窗: From the end of treatment at 3 years
Incidence of grade 2-3 late toxicity in terms of skin toxicity
次要结局
- Incidence of local tumor relapse, distant metastasis and assessment of overall survival(Time from the date of the diagnosis of primary breast cancer to the date of diagnosis of local relapse, distant metastasis or death from any cause, assessed up to 60 months)
研究者
Silvia Takanen
Principal Investigator
Regina Elena Cancer Institute
研究点 (2)
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