Clinical trial NCT05263362: 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)
Official title: An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Fibrosis
Breast Cancer
Breast Cancer Female
Breast Neoplasms
Breast Carcinoma in Situ
Breast Carcinoma
Keywords: Fibrosis
Cosmetic outcome
Quality of life
Oncoplastic breast surgery
Radiotherapy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Stichting BeterKeten, the Netherlands
name: Albert Schweitzer Ziekenhuis, Netherlands
name: Franciscus Gasthuis and Vlietland Hospital, Rotterdam and Schiedam, the Netherlands
name: Maasstad hospital, Rotterdam, the Netherlands
First posted: 2022-03-02
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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 radiotherapy of the whole breast at the Erasmus MC as part of their BCT.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fibrosis of the breast as measured by CTCAE v5 scale
timeFrame: 2-6 years after breast conserving treatment. 1 point of measurement.
measure: Cosmetic outcome as measured by 9-item questionnaire
timeFrame: 2-6 years after breast conserving treatment. 1 point of measurement.
measure: Cosmetic outcome as measured by BCCT.core software
timeFrame: 2-6 years after breast conserving treatment. 1 point of measurement.
Secondary outcomes:
measure: Quality of life, as measured by BREAST-Q
timeFrame: 2-6 years after breast conserving treatment. 1 point of measurement.
measure: Quality of life, as measured by EORTC Quality of Life Questionnaires-C30
timeFrame: 2-6 years after breast conserving treatment. 1 point of measurement.
measure: Quality of life, as measured by EORTC Quality of Life Questionnaires-B23
timeFrame: 2-6 years after breast conserving treatment. 1 point of measurement.
measure: Quality of life, as measured by EQ-5D-5L - five dimensions
timeFrame: 2-6 years after breast conserving treatment. 1 point of measurement.
measure: Quality of life, as measured by EQ-5D-5L - VAS
timeFrame: 2-6 years after breast conserving treatment. 1 point of measurement.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Maasstad hospital
city: Schiedam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
Study officials:
affiliation: Erasmus Medical Center
name: R.A. Nout, Professor
role: STUDY_DIRECTOR
affiliation: Erasmus Medical Center
name: E.A.M. Froklage, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Schweitzer Hospital
name: M.B.E. Menke-Pluijmers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: