Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy: Evaluation of the Toxicity and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- acute and tardive toxicity according to NCI-CTCAE v4.0
研究概览
简要总结
Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. The adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.
详细描述
Patients responding criteria for selection and not objecting to participate in this trial will address the quality of life questionnaires at baseline and during their standard follow-up (1, 6, 12 and 24 months after the end of radiotherapy). The data of toxicity and disease-free survival will be collected from data on medical record of the patient.
The therapeutic support and monitoring are standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •1-Patient with breast cancer proved by histology and treated surgically
- •Relevant of adjuvant radiotherapy after partial or total mastectomy with or without lymph node irradiation 3- Age ≥ 18 years 4- Information and no opposition to the patient
排除标准
- •- Metastatic disease
- •- Patient having another severe disease or uncontrolled which could jeopardize the trial participation
- •- pregnant or breastfeeding woman 4-inability to do follow-up medical care of clinical trial for geographical, social or psychological reasons
结局指标
主要结局
acute and tardive toxicity according to NCI-CTCAE v4.0
时间窗: up to 5 years
according to NCI-CTCAE v4.0
次要结局
- Disease free survival(up to 5 years)
- Quality of life according to QLQC-30(up to 24 months)
- Quality of life according to BR-23 module(up to 24 months)
- esthetic results(up to 5 years)