Clinical trial · Observational
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)
An Integrated Optimization of Surgery and Radiotherapy Techniques to Improve Cosmetic Outcome and Quality of Life in Breast Conserving Therapy for Breast Cancer Patients.
NCT05263362CI-TRIAL-00108048STARLINGScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | — | UNRESOLVED | — |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Carcinoma in Situ | Breast Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Breast Fibrosis | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Other: no intervention
Primary outcomes (3)
- measure
- Fibrosis of the breast as measured by CTCAE v5 scale
- timeFrame
- 2-6 years after breast conserving treatment. 1 point of measurement.
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNotenboom MCAW, Klem TMAL, Contant CME, Ribbe SP, Franckena M, Penninkhof JJ, Koppert LB, Plaisier PW, Mureau MAM, van Werkhoven ED, van der Veen FJC, de Kraker M, Nout RA, Menke-Pluijmers MBE, Froklage FE. The association between breast fibrosis, cosmetic outcomes, and long-term health-related quality of life after breast-conserving therapy: a multicenter cross-sectional observational cohort study. Breast. 2025 Oct;83:104541. doi: 10.1016/j.breast.2025.104541. Epub 2025 Jul 14. PMID 40774221