Status:
COMPLETED
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)
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Albert Schweitzer Ziekenhuis, Netherlands
Conditions:
Breast Fibrosis
Breast Cancer
Eligibility:
FEMALE
18+ years
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 moder...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 20 2024
Estimated Enrollment :
775 Patients enrolled
Trial Details
Trial ID
NCT05263362
Start Date
April 11 2022
End Date
September 20 2024
Last Update
November 26 2025
Active Locations (4)
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1
Albert Schweitzer hospital
Dordrecht, Netherlands
2
Erasmus Medical Center
Rotterdam, Netherlands
3
Maasstad hospital
Rotterdam, Netherlands
4
Franciscus Gasthuis & Vlietland
Schiedam, Netherlands