Evaluation of Dose Integrated Accelerated Irradiation in Older Women (≥ 70 Year) With Early and Loco-regionally Advanced Stages of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Breast retraction (LENTSOMA)
研究概览
简要总结
Adjuvant radiotherapy in breast cancer improves local control, also in the elderly. Hormonal therapy in hormone sensitive tumors improves results but can not substitute radiotherapy. Improved local control leads to less breast cancer related morbidity and mortality, also in an older population (Schonberg, JCO, 2011).
Unfortunately, in older patients with lower life expectancy, adjuvant radiotherapy is often omitted. Following reasons are invoked:
- frailty of the patient
- fear for toxicity
- impaired mobility, rendering transportation and positioning more difficult
- dependency for transportation to and from the radiotherapy departement
- negative cost effectiveness ratio, due to high cost (especially for complex techniques and long schedules) and lower benefit (lower life expectancy)
Hypofractionation is feasible without increased toxicity, and combines better local control with patient comfort and lower costs. Further lowering the number of fractions (from 15-21 to 5) will further improve patient comfort, but is challenging when different doses are needed in the same target volume. This problem is addressed using advanced techniques permitting dose-integration.
In the elder with cancer, several unrecognized geriatric problems, including depression and cognitive impairment, can be detected by CGA . Some problems do interact with cancer treatment. In this study screening and assessment is provided to support patients and to develop an inventory of radiotherapy obstacles.
Our study includes breast cancer patients, ≥70 years old, referred for adjuvant radiotherapy after surgical treatment. A schedule of 5 fractions is offered, encompassing different targets of treatment.
详细描述
Adjuvant radiotherapy in breast cancer improves local control and overall survival, also in the elderly. Hormonal therapy in hormone sensitive tumors improves results but can not substitute radiotherapy (EBCTCG, Lancet, 2011). Improved local control, leads to less breast cancer related morbidity and mortality, also in an older population (Schonberg, JCO, 2011).
Unfortunately, in older patients with lower life expectancy, adjuvant radiotherapy is often perceived as too cumbersome. As a consequence, patients who could have benefit from breast conserving therapy are referred for mastectomy. Even when breast-conserving surgery is chosen, adjuvant radiotherapy is sometimes omitted in frail patients over 70 years fearing the burden of daily transportation to the radiation department. However, omitting radiotherapy results in a higher risk of loco-regional recurrence. It has been shown that older patients have a worse prognosis due to suboptimal treatment, especially in locally advanced breast cancer (Schonberg, JCO, 2011).
Following reasons are invoked by the patients or the care-givers:
- frailty of the patient
- fear for (mostly acute) toxicity
- impaired mobility, rendering transportation and positioning more difficult
- dependency on third parties (family, services) for transportation to and from the radiotherapy departement
- negative cost effectiveness ratio, due to high cost (especially for complex techniques and long schedules) and lower benefit (lower life expectancy)
Hypofractionation and acceleration are proven to be feasible in recent trials (cf. Start Trial, Fast Trial).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 70 years old
- •AND breast conserving surgery or mastectomy for breast carcinoma
- •AND multidisciplinary decision of adjuvant irradiation
- •AND absence of distant metastases
- •AND informed consent obtained, signed and dated before specific protocol procedures
排除标准
- •Bilateral breast irradiation
- •In case of mastectomy: positive resection margin, needing boost
- •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
- •History of previous radiation treatment to the same region
研究组 & 干预措施
Accelerated dose-integrated radiotherapy - pN0
Lymph node negative breast cancer
干预措施: Dose-integrated accelerated EBRT in pN0 breast cancer (Radiation)
Accelerated dose-integrated radiotherapy - pN1
Lymph node positive breast cancer
干预措施: Dose-integrated accelerated EBRT in pN+ breast cancer (Radiation)
结局指标
主要结局
Breast retraction (LENTSOMA)
时间窗: 6 weeks post-radiotherapy
Breast Cancer Conservative treatment.core (BCCT.core) objective measurement
次要结局
- Acute toxicity: number of patients with clinical relevant dermatitis (CTCAE v. 4.0)(1-8 weeks)
- Acute toxicity: number of patients with moist desquamation (CTCAE v. 4.0 (grade 3)(1-8 weeks)
- Acute toxicity: number of patients with pain (CTCAE v. 4.0)(1-8 weeks)
- Acute toxicity: number of patients with pruritus (CTCAE v. 4.0)(1-8 weeks)
- Acute toxicity: number of patients with fatigue (MFI-20)(1-8 weeks)
- Chronic toxicity: measurement of patient satisfaction with breast esthetic outcome: BREAST-Q questionnaire(Before radiotherapy and after 2 and 5 years)
- Chronic toxicity: prevalence of fibrosis(2 and 5 years)
- Chronic toxicity: prevalence of pain(2 and 5 years)
- Chronic toxicity: prevalence of telangiectasia(2 and 5 years)
- Breast cancer specific survival(2 and 5 years)
- Overall survival(2 and 5 years)
- Chronic toxicity: prevalence of lymphedema(2 and 5 years)
- Chronic toxicity: prevalence of fatigue (MFI-20)(2 and 5 years)
- Chronic toxicity - prevalence of radiation induced brachial plexopathy (RIBP) (standardized screening questionnaire), confirmed by electromyogram (EMG)(2 and 5 years)
- Loco-regional tumor control(2 and 5 years)
- Distant tumor control(2 and 5 years)