An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients (STARLINGS Study)

Erasmus Medical Center775 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

775

Conditions

Breast Fibrosis Breast Cancer Breast Cancer Female Breast Neoplasms Breast Carcinoma in Situ Breast Carcinoma

no interventionOTHER

At one timepoint patients will get physical examination of the breasts, medical photographs will be taken, and they will fill in five questionnaires about satisfaction of the breasts, quality of life and general health.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (4)

Albert Schweitzer hospital

Dordrecht, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Maasstad hospital

Rotterdam, Netherlands

Franciscus Gasthuis & Vlietland

Schiedam, Netherlands

Outcomes

Primary Outcomes

Fibrosis of the breast as measured by CTCAE v5 scale

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).