Feasibility Study of Accelerated Preoperative Radiotherapy for Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Quantity of blood lost
研究概览
简要总结
The standard treatment for women with a relatively small breast cancer without arguments for involvement of the axillary lymph nodes, is breast conserving surgery followed by radiotherapy of the whole breast, often with a complementary dose to the operated area (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before the start of radiotherapy. Historically, whole breast radiotherapy plus boost are delivered in 6-7 weeks. This treatment can be associated with temporary fatigue and decrease in quality of life. Randomized trials have shown that shorter schedules, delivering slightly more dose per day during 3 weeks, are equal to the long schedules. In an earlier clinical study, the investigators have tested such a short schedule and shown that it is equally safe and equally well tolerated as the conventional schemes. Other hospitals have examined (and still are examining) the safety and tolerance of even shorter schedules, delivering radiotherapy in 1 week.
This clinical study involves delivering radiotherapy in 1 week and before the surgery in stead of following surgery. In the postoperative setting, it is often debatable which volume should be included in the boost. Often boost-volumes remain large because of uncertainties in delineation. Preoperative radiotherapy has the advantage that the tumor is visible on imaging. This can result in smaller boost volumes. The surgery will follow shortly after termination of the radiotherapy, resulting in a very short treatment period.
This study is an open study investigating the effect on quality of life of a very short preoperative radiotherapy for early breast cancer.
详细描述
Women with early breast cancer are treated with breast conserving surgery (BCS) followed by whole breast irradiation (WBI) and a complementary dose to the lumpectomy cavity (boost). A delay of 3-4 weeks after surgery is advisable for allowing wound healing before the start of radiotherapy. Historically, WBI plus boost are delivered in 6-7 weeks. This treatment is associated with fatigue and a decreased quality of life. Randomized trials have shown that shorter hypofractionated schedules, delivering radiotherapy in 3 weeks, are equal to the long schedules. The investigators have shown that a hypofractionated tomotherapy with a simultaneous integrated boost is oncologically safe, well tolerated and has less impact on quality of life than the conventional schemes.
In the postoperative setting, it is often debatable which volume should be included in the boost. Surgical clips can help to decrease inter-observer variability, but often boost-volumes remain large because of uncertainties in delineation. Preoperative radiotherapy has the advantage that the gross tumor volume (GTV) is visible on imaging. This can result in smaller boost volumes.
The aim of this study is to investigate the feasibility of a short preoperative tomotherapy. The potential benefits are
- a decrease in overall treatment time
- a positive effect on quality of life
- a more precise target delineation
- profitable health economics.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histological diagnosis of unifocal invasive breast carcinoma, no special type (ductal carcinoma)
- •Tumor Staging: cT1-2N0M0
- •Luminal A or B
- •Candidate for breast conserving surgery
- •N0-status confirmed by lymph node cytology
排除标准
- •Multifocal/multicentric disease
- •Prior thoracic radiotherapy
- •Pregnancy
- •SBR3 grading
- •Triple negative status which benefit neoadjuvant chemotherapy
结局指标
主要结局
Quantity of blood lost
时间窗: from 2 to 8 days after the last radiotherapy session.
Quantity of blood that has been lost during the breast conservation surgery, performed 2 to 8 days after the last radiotherapy session.
Wound infection (yes/no)
时间窗: up to 30 days post operative
Presence of wound infection, defined as: purulent drainage, cellulitis, abscess or wound requiring drainage, debriding, and antibiotics associated with a clinical diagnosis of infection.
Number of adverse events
时间窗: up to three months after radiotherapy start
Acute radiation toxicity measure
Dindo score
时间窗: Week 6 after radiotherapy start
Post operative morbidity assessment according to Dindo, Demartines et al.
Duration of the surgical procedure
时间窗: from 2 to 8 days after the last radiotherapy session.
Duration of the breast conserving surgery (lumpectomy + sentinel lymph node procedure)
Wound disruption (yes/no)
时间窗: up to 30 days post operative
Presence of wound disruption defined as skin dehiscence from any cause including seroma or hematoma.
次要结局
- QLQ-C30 questionnaire(week 6 after radiotherapy start)
- EORTC QLQ-BR23 questionnaire(week 6 after radiotherapy start)
- Number of adverse events(from three months after radiotherapy start till end of study (up to 1 years))
- Local recurrence (yes/no)(up till the end of study (1 year))
研究者
Andre Nazac
Head of clinic
Brugmann University Hospital