Randomized Phase III Trial Comparing Intensity Modulated Radiotherapy With Integrated Boost to Conventional Radiotherapy With Consecutive Boost in Patients With Breast Cancer After Breast Conserving Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 502
- 试验地点
- 3
- 主要终点
- cosmetic results
研究概览
简要总结
The IMRT-MC2 study is a prospective, two armed, multicenter, randomized phase-III-trial comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy with consecutive boost in patients with breast cancer after breast conserving surgery. 502 patients will be recruited and randomized in two arms: patients in arm A will receive IMRT in 28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor-bed by an integrated boost, while patients in arm B will receive conventional radiotherapy of the breast in 28 fractions to a dose of 50.4 Gy and a consecutive boost in 8 fractions to a total dose of 66.4 Gy. Primary aim of the study is the assessment of the cosmetic outcome and local control after breast radiotherapy. The study hypothesis is that intensity modulated radiotherapy (IMRT) is, in spite of the reduced treatment duration, at least equivalent to conventional therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •All patients aged >18 years and < 70 years after breast conserving surgery.
- •Patients aged ≥ 70 years with following risk factors:
- •Tumor stadium ≥ T2
- •Multifocal disease
- •Lymphangiosis
- •Extended intraductal component
- •Resection margin ≤3mm
排除标准
- •Refusal of the patients to be included in the study
- •Karnofsky Performance Score ≤ 70%
- •Metastatic disease (M1)
- •Other malignancies
- •Previous radiotherapy of the breast
- •Pregnancy
结局指标
主要结局
cosmetic results
时间窗: 2 years
The cosmetic outcome will be assessed by two independent investigators using the Harvard criteria (excellent, good, fair, poor). Additional parameters to be evaluated are skin color, teleangiectasy, scars, shrinking and asymmetry. Evaluation will also be carried out using a quantitative digitizer scoring system based on standardized photodocumentations of the breast, as described by Vrieling et al.. by calculation of a breast retraction assessment (BRA) score.
local recurrence rates
时间窗: 5 years
次要结局
- fraction of patients surviving (overall survival)(15 years)
- fraction of patients surviving without tumor recurrence (disease-free survival)(15 years)
- quality of life(2 years)
- occurence of secondary malignancies(15 years)