An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 775
- 试验地点
- 6
- 主要终点
- Cosmetic outcome as measured by 9-item questionnaire
研究概览
简要总结
To assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome.
详细描述
The primary objectives of this study are to assess the role of different combinations of (oncoplastic) surgery and radiotherapy techniques as risk factors for moderate to severe fibrosis and for moderate to poor cosmetic outcome. Based on these insights predictive models for the development of moderate to severe fibrosis and moderate to poor cosmetic outcome will be developed. Second, the relation between the presence and severity of fibrosis, cosmetic outcome and different QoL domains and symptoms will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 aged ≥ 18 years
- •History of BCT with adjuvant radiation therapy for non-metastatic, histologically proven invasive breast cancer or DCIS. In light of BCT adjuvant systemic treatment (i.e. endocrine therapy, chemotherapy and immune therapy) is allowed.
- •Operated between 1st of January 2016 and 31th of December 2020
- •Treated according to the currently applied dose fractionation schedules, i.e. whole breast radiotherapy (22, 23), with or without boost
- •Adequate understanding of the Dutch language and written informed consent
排除标准
- •Any breast surgery or re-irradiation on the breast area after BCT
- •Progression of disease (and additional treatment) since BCT
- •Patients who received partial breast irradiation
- •Current pregnancy or breast feeding
研究组 & 干预措施
STARLINGS study population
The study population consists of breast cancer patients who were treated with breast conserving therapy (BCT) at one of the four participating hospitals (Erasmus MC, Albert Schweitzer hospital, Maasstad hospital and Franciscus hospital Gasthuis and Vlietland), for non-metastatic, histological proven invasive breast cancer or DCIS between 2016 and 2020 (at time of inclusion in 2022 respectively 6 to 2 years after treatment), and subsequently received adjuvant (whole breast) irradiation (WBI), with or without boost, at the Erasmus MC as part of their BCT.
干预措施: no intervention (Other)
结局指标
主要结局
Cosmetic outcome as measured by 9-item questionnaire
时间窗: 2-6 years after breast conserving treatment. 1 point of measurement.
Cosmetic outcome will be evaluated by means of a 9-item cosmetic patient questionnaire filled out by the patient with scoring on a four point scale (range from 'excellent' to 'poor' per item).
Cosmetic outcome as measured by BCCT.core software
时间窗: 2-6 years after breast conserving treatment. 1 point of measurement.
Patients' photographs of the breasts will be taken. With the use of BCCT.core software from The Breast Research group (INESC TEC, the Faculdade de Medicina da Universidade do Porto) cosmetic outcome will be assessed.
Fibrosis of the breast as measured by CTCAE v5 scale
时间窗: 2-6 years after breast conserving treatment. 1 point of measurement.
Fibrosis will be graded by the researcher using the CTCAE v5 scale. On the CTCAE scale of superficial soft tissue fibrosis: Grade 0 = no fibrosis, Grade 1 = mild induration, able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up), Grade 2 = Moderate induration, able to slide skin, unable to pinch skin; limiting instrumental ADL, Grade 3 = Severe induration; unable to slide or pinch skin; limiting joint or orifice movement (e.g., mouth, anus); limiting self care ADL, Grade 4 = Generalized; associated with signs or symptoms of impaired breathing or feeding, Grade 5 = Death. We are planning to score fibrosis of the breast as none/mild (grade 0-1) or moderate/severe (grade 2-3).
次要结局
- Quality of life, as measured by EORTC Quality of Life Questionnaires-C30(2-6 years after breast conserving treatment. 1 point of measurement.)
- Quality of life, as measured by EORTC Quality of Life Questionnaires-B23(2-6 years after breast conserving treatment. 1 point of measurement.)
- Quality of life, as measured by BREAST-Q(2-6 years after breast conserving treatment. 1 point of measurement.)
- Quality of life, as measured by EQ-5D-5L - VAS(2-6 years after breast conserving treatment. 1 point of measurement.)
- Quality of life, as measured by EQ-5D-5L - five dimensions(2-6 years after breast conserving treatment. 1 point of measurement.)
研究者
E. (Euphemia) A.M. Froklage
MD, PhD, Principal Investigator
Erasmus Medical Center