Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Changes in Cosmetic results - BCCT
研究概览
简要总结
To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy
详细描述
To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy.
- •Not pregnant at diagnosis.
- •Signed informed consent form.
- •Age ≥45 years old.
- •Patients candidates to Intrabeam.
- •Patients with ≥60 years with the presence of one or more of the following adverse criteria after surgery:
- •Tumor size > 2.5 cm.
- •Extensive intraductal carcinoma (≥25%)
- •Lymphovascular invasion.
- •Involved focal margins (<2mm) without ampliation surgery.
排除标准
- •Presence of distant metastasis.
- •Primary chemotherapy.
- •Lymph node involvement.
- •Negative hormonal receptors.
- •Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas
- •Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
- •Uncontrolled infection.
- •Concurrent treatment with other experimental treatments
- •Lack of signed informed consent form.
结局指标
主要结局
Changes in Cosmetic results - BCCT
时间窗: Baseline and every 12 months until 60 months
It will be measured by the BCCT.core software programme. This software uses 4 photographies of the breast for each timepoint and evaluates cosmetic outcome based upon symmetry, skin colour changes and surgical scar appearance. The lower the calculated score, the better the cosmetic outcome (1=excellent, 2=good, 3=fair, 4=poor)
Changes in Cosmetic results - Self Evaluation using YBT
时间窗: Baseline and every 12 months until 60 months
Questionnaire for cosmetic self-evaluation from the Young Boost Trial (YBT) that consists s of 8 questions about various aspects (size, shape, skin colour, massiveness of the breast, nipple position, general appearance, visibility of the surgical scar, and overall satisfaction) to evaluate the degree of satisfaction of the patients themselves about the cosmetic results.
次要结局
- Changes in Quality of life (QOL) - General(Baseline and every 12 months until 60 months)
- Changes in Quality of life (QOL) - Breast(Baseline and every 12 months until 60 months)
- Toxicity (acute and late)(Baseline and every 12 months until 60 months)
- Local control(Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years)