Whole Breast (WB) + Lymph Node Irradiation (LNI): Prone Compared to Supine Position in a Randomized Study With 15 or 5 Fractions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Breast retraction
研究概览
简要总结
The goal of this trial is to evaluate the effect of the prone crawl treatment position and/or accelerated schedule on acute and late toxicities, as well as quality of life and time management for breast cancer patients receiving whole breast and regional nodal irradiation after breast conserving surgery.
详细描述
Locoregional radiotherapy after lumpectomy and axillary node dissection diminishes the locoregional recurrence risk at 10 years by 21,2 % in women with pathologically confirmed lymph node involvement.
Excess dose to organs at risk can lead to acute and late side effects, such as tissue damage, organ malfunction and secondary cancers. Radiotherapy in prone position has helped reduce these risks for whole breast radiotherapy only, but has not yet been adequately investigated for patients also requiring regional nodal irradiation. One of the reasons is that there is no optimal patient support device available to allow regional nodal irradiation in prone position. To this end, a novel positioning device was developed at our center, allowing regional nodal irradiation in prone position. It was called the crawl breast couch because the patient position resembles a phase from the crawl swimming technique. A previous planning study by Deseyne et al. using this device shows a benefit (i.e. reduced dose) for the ipsilateral lung, the thyroid, as well as a minor benefit for the right lung, and contralateral breast (which already receive very low relative doses) while maintaining similar target coverage when compared to supine positioning.
Apart from the paradigm shift from supine to prone radiotherapy, in recent years, it has become clear that breast cancer cells are more sensitive to fraction dose than originally presumed. Large randomized trials confirm this hypothesis: moderate hypofractionation schemes in 15 or 16 fractions are at least equivalent in tumor control and toxicity although the total dose is lower than the traditional 50 Gy in 25 fractions. Further acceleration to 5 fractions is expected to have an even larger radiobiological advantage regarding tumor control. Additional advantages are patient comfort and a better use of radiotherapy resources.
This randomized trial with 2 x 2 factorial design tests 2 interventions for patients with breast cancer requiring whole-breast and regional nodal irradiation: radiotherapy in prone position with a specifically designed patient support device called the crawl breast couch, and accelerated radiotherapy in 5 fractions. The standard arm in this trial is supine hypofractionated radiotherapy.
The goal of this trial is to evaluate the effect of the prone crawl treatment position and/or accelerated schedule on acute and late toxicities, as well as quality of life and time management for breast cancer patients receiving whole breast and regional nodal irradiation after breast conserving surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Breast conserving surgery
- •AND Multidisciplinary decision of adjuvant whole breast + regional nodal irradiation
- •AND Informed consent obtained, signed and dated before specific protocol procedures
排除标准
- •Mastectomy
- •OR Bilateral breast irradiation
- •OR Distant metastasis/metastases
- •OR previous irradiation to the thoracic, cervical or axillary region and overlap of fields with current treatment
- •OR life expectancy of less than 2 years
- •OR pre-existing conditions or comorbidities making toxicity evaluation difficult, e.g. skin disorders
- •OR pregnant or breast feeding
- •OR mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •OR patient unlikely to complete the study
结局指标
主要结局
Breast retraction
时间窗: 2 years after radiotherapy
Rate of breast retraction or volume loss after radiotherapy
次要结局
- Acute toxicity - Desquamation(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Dysphagia(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Dyspnea(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Cardiac toxicity(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Setup accuracy(Before each scheduled radiation treatment session (every treatment day starting from radiotherapy start until ± 3 weeks later))
- Treatment cost(Baseline, 1st visit after radiotherapy and at year 1, 2 and 5)
- Acute toxicity - Breast oedema(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Arm Symptoms - Sense of heaviness(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Shoulder range of motion(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Arm circumference(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Breast symptoms - sense of heaviness(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Breast symptoms - itching(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Arm Symptoms - Pain(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Shoulder symptoms - Pain(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Quality of life - Breast specific questionnaire(At baseline and at 1, 2 and 5 years after radiotherapy)
- Volume parameters of targets/organs at risk/hot spots - volume of the structures(After treatment planning (Week 1-2 after inclusion))
- Acute toxicity - Dermatitis(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Shoulder symptoms - Impaired shoulder mobility(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Non-breast retraction late treatment related toxicity(Baseline and from 6 months post radiotherapy until 5 years after radiotherapy)
- Volume parameters of targets/organs at risk - relative volume receiving a certain dose(After treatment planning (Week 1-2 after inclusion))
- Cosmesis(Baseline, 1st visit after radiotherapy and at year 1, 2 and 5)
- Quality of life - General(At baseline and at 1, 2 and 5 years after radiotherapy)
- Treatment duration(At 3 weeks)
- Dose parameters of target tissues/organs at risk(After treatment planning (Week 1-2 after inclusion))
- Acute toxicity - Breast symptoms - pain(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Pain not in arm/shoulder/breast(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Acute toxicity - Cough(Baseline and from radiation initiation until 8-16 days after radiation treatment)
- Locoregional and distant tumor control(At 1, 2 and 5 years after radiotherapy)