A Partially Randomized Patient Preference Trial, Comparing Adjuvant Hypofractionated Radiotherapy in 15 Versus 5 Fractions After Breast Conserving Surgery or Mastectomy for Early or Locally Advanced Breast Cancer in Women Above 65 Years
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Breast retraction (LENTSOMA)
研究概览
简要总结
This study will evaluate the effect of highly accelerated external beam radiotherapy (EBRT) in 5 fractions over 10 days compared to 15 fractions over 3 weeks for early as well as locally-advanced stage breast cancer.
Primary endpoint will be chronic toxicity (breast deformation and retraction). Secondary endpoints are acute toxicity, loco-regional and distant tumor control, patient reported QoL and cosmetic satisfaction. Patients with lymph node irradiation will be closely monitored for radiation induced plexopathy.
详细描述
Over the age of 65, uptake of adjuvant radiotherapy after surgery for breast cancer declines, even in women with poor prognostic stage or adverse tumor characteristics.
Lowering the number of fractions may reduce reluctancy for radiotherapy in this age group.
In a preceding prospective phase I-II trial, evaluating EBRT over 10 days, results on technical feasibility and acute toxicity were positively evaluated.
However, data on the chronic effects of breast irradiation using high doses per fraction are still sparse.
This trial is developed to compare standard hypo-fractionation in 15 fractions (if needed with simultaneously integrated boost - SIB) with highly accelerated radiotherapy in 5 fractions.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast conserving surgery or mastectomy for breast carcinoma
- •multidisciplinary decision of adjuvant irradiation
- •absence of distant metastases
- •informed consent obtained, signed and dated before specific protocol procedures
排除标准
- •History of previous radiation treatment to the same region
- •Bilateral breast irradiation
- •Life expectancy of less than 2 years
- •Planned reconstructive breast surgery
- •Condition making toxicity evaluation difficult, e.g. skin disorders, pre-existing brachial plexus injury, ...
- •Inability to respect constraints on skin, heart, lungs, esophagus, ribs, brachial plexus or any other organ at risk
- •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 or unlikely to complete the study
结局指标
主要结局
Breast retraction (LENTSOMA)
时间窗: 2-5 years
Breast Cancer Conservative treatment.core (BCCT.core) objective measurement
次要结局
- Acute toxicity: number of patients with moist desquamation(1-8 weeks)
- Overall survival(2 and 5 years)
- Acute toxicity: number of patients with pain (CTCAE v. 4.0)(1-8 weeks)
- Acute toxicity: number of patients with clinical relevant dermatitis (CTCAE v. 4.0)(1-8 weeks)
- Chronic toxicity: measurement of patient satisfaction with breast esthetic outcome(Before radiotherapy and after 2 and 5 years)
- Chronic toxicity - prevalence of radiation induced brachial plexopathy (RIBP) (standardized screening questionnaire), confirmed by electromyogram (EMG)(2 and 5 years)
- Breast cancer specific survival(2 and 5 years)
- Chronic toxicity: prevalence of lymphedema(2 and 5 years)
- Distant tumor control(2 and 5 years)
- Acute toxicity: number of patients with fatigue (MFI-20)(1-8 weeks)
- Chronic toxicity: prevalence of telangiectasia(2 and 5 years)
- Chronic toxicity: prevalence of fatigue (MFI-20)(2 and 5 years)
- Loco-regional tumor control(2 and 5 years)
- Acute toxicity: number of patients with pruritus (CTCAE v. 4.0)(1-8 weeks)
- Chronic toxicity: prevalence of fibrosis(2 and 5 years)
- Chronic toxicity: prevalence of pain(2 and 5 years)