Medico Economic Study, Randomized, Comparing Intraoperative Radiotherapy With Intrabeam® on Surgical Resection Bed Versus Conventional Surgery + EBRT in Postmenopausal Patients Operated by Conservative Surgery for Low Risk Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 246
- 试验地点
- 16
- 主要终点
- Actual cost
研究概览
简要总结
Current breast cancer treatment is based on surgery, radiation, chemotherapy and hormonotherapy. Conservative surgery or mastectomy are followed by complementary externe radiotherapy.
This adjuvant external breast radiotherapy (EBRT) is heavy, spread over more than 6 weeks with :
- 25 sessions and delivery of a unit dose of 2 Gy to obtain a total dose of 50 Gy (5 sessions per week in general);
- 16 Gy overimpression (boost) dose located in the tumour bed, in 5 to 8 fractions, in situations at high risk of recurrence.
In addition, EBRT is responsible for many adverse effects, some of which can lead to lasting or permanent sequelae.
Many focused partial breast irradiation techniques have been developed in recent years with the objective of reducing the duration and morbidity of overall breast irradiation.
Among these techniques, intraoperative breast radiotherapy (IBRT) is recommended in cancers diagnosed at early stages for which tumorectomy is expected and which present a low risk of recurrence.
The main advantages of IBRTare :
- Improvement of the quality of life due to a single session of radiotherapy associated with surgical ;
- Increased precision to deliver the necessary dose in tumour tissue;
- Preservation of surrounding healthy tissue ;
- Reduction in the overall cost of treatment through shorter hospital stays and the absence of medical transport for conventional radiotherapy sessions.
RIOP SEIN is a project supported by Institut National du Cancer (INCa)
, which consists of a medico-economic evaluation of IBRT, with Intrabeam® system on surgical resection bed relative to conventional surgery + EBRT in postmenopausal patients operated by conservative surgery for Low risk breast cancer
详细描述
Main objective is the economic comparison Intrabeam® system versus EBRT, in terms of real costs. Costs will be taken into account:
- of equipment,
- of staff,
- of transport.
Secondary objectives are :
- Compare local-regional survival without recurrence with conventional irradiation
- Analyze the rate of early and late complications
- Impact of intraoperative irradiation on the esthetic outcome and quality of life of patients
Schedule of the visits :
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven invasive ductal breast cancer,
- •Menopausal women at least 55 years old,
- •Clinical and ultrasound size ≤ to 20 mm, N0,
- •Biopsy with all following criteria: SBR I or II, HER2 (0, +, ++ with FISH or SISH required), positive estrogen receptors, no embolus
- •No personal history of breast cancer or BRCA gene mutation.
- •Social insurance
- •Signed consent
排除标准
- •Bifocal or bilateral breast cancer,
- •Presence of invasive ductal carcinoma with diffuse micro calcifications on mammography,
- •Invasive lobular carcinoma,
- •Presence of lymph node involvement,
- •History of malignant disease if life expectancy without recurrence at 10 years <90%,
- •Adult under guardianship,
- •History of chest radiation therapy (Hodgkin's).
结局指标
主要结局
Actual cost
时间窗: 2 months after the end of radiotherapy
Actual cost measured individually for each patient for both techniques used, involving all costs from surgery to 2 months after the end of radiotherapy including costs related to possible acute complications of radiotherapy
次要结局
- Complication rates(10 years)
- Esthetic result(10 years)
- Local-regional recurrence rate(10 years)
- quality of life after surgery and radiotherapy(10 years)