Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy.
研究概览
简要总结
Whole breast irradiation (WBI) after breast conserving surgery for early-stage breast cancer halves the recurrence risk and reduces the breast cancer death by about one sixth. A sequential boost (SeqB) dose to the tumour bed further improves local control, but also increases the risk of late skin toxicity and cosmetic changes. At Ghent University Hospital WBI is prescribed in 15 fractions of 2.67 Gy according to the START-B hypofractionation scheme. A sequential boost is typically given in 4 to 8 extra fractions which prolongs the overall treatment time. The boost dose can also be delivered within the 15 fractions of WBI, the so-called simultaneous integrated boost (SIB). SIB shortens the overall treatment time which is convenient for the patient and the radiotherapy department. In this study we wish to test the hypothesis of acceptable skin toxicity and reduced cost with SIB using hypofractionated prone intensity modulation radiotherapy IMRT with topographical dose painting, a technique recently developed in our group. Patients are randomized between SeqB and SIB.
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
- •Female patients AND breast conserving surgery AND multidisciplinary decision of adjuvant WBI with a boost to the tumor bed AND age ≥ 18 years AND informed consent obtained, signed and dated before specific protocol procedures
排除标准
- •Mastectomy
- •Need for lymph node irradiation
- •Bilateral breast irradiation
- •Patient not able to reach or maintain the prone position
- •Pregnant or breastfeeding
- •Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
研究组 & 干预措施
Minimal surgical margin 1 mm, conventional arm: seq boost
Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost).
干预措施: sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost) (Radiation)
Minimal surgical margin of 1 mm, experimental arm with SIB
Minimal surgical margin of 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)
干预措施: SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy) (Radiation)
Minimal surgical margin <1 mm, conventional arm: seq boost
Minimal surgical margin < 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)
干预措施: sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost) (Radiation)
Minimal surgical margin < 1 mm, experimental arm with SIB.
Minimal surgical margin < 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)
干预措施: SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy) (Radiation)
结局指标
主要结局
Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy.
时间窗: weekly during radiotherapy, 2 weeks after the end of radiotherapy.
Clinical inspection of the treated breast.
次要结局
- Degree of chronic skin toxicity and cosmesis after radiotherapy.(2 weeks, 1 year, 2 years and 5 years after radiotherapy.)
- Degree of acute skin toxicity.(Weekly during radiotherapy and 2 weeks after the end of radiotherapy.)
- Measurement of costs for the patient for the full treatment.(Over the period of radiotherapy treatment, with a maximum of 5 weeks.)
- Quality of life after radiotherapy.(2 weeks, 1 year, 2 years and 5 years after radiotherapy.)
- Biomarker analysis.(Blood sample within 1 week before the start of radiotherapy)