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 University

Status: Completed

Conditions: Breast Cancer; Breast Fibrosis; Breast Cancer Female; Breast Carcinoma in Situ; Breast Neoplasms; Breast Carcinoma

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05263362

MEC-2021-0829

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 775 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

775 participants in 1 patient group

STARLINGS study population

Description:

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.

Treatment:

Other: no intervention