An integrated optimization of Surgery and radioTherApy techniques to impRove cosmetic outcome and quaLity of life In breast conserviNG therapy for breaSt cancer patient

An integrated optimization of surgery and radiotherapy techniques to improve cosmetic outcome and quality of life in breast conserving therapy for breast cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22078

Enrollment

750

Registered

2021-10-27

Start date

2021-09-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • Female patients aged = 18 years • History of BCT with adjuvant radiation therapy for non-metastatic, histologically proven invasive breast cancer (pT1-3N0-2a) or DCIS. In light of BCT adjuvant systemic treatment (i.e. endocrine therapy, chemotherapy and immune therapy) is allowed. • Breast conserving surgery between 1st of January 2016 and 31th of December 2018 • Treated according to the currently applied dose fractionation schedules, i.e. whole breast radiotherapy, with or without boost • Adequate understanding of the Dutch language and written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary focus of this project will be to determine which different combinations of (oncoplastic reconstructive) surgery and radiotherapy techniques, in the context of breast conserving therapy for (pre-invasive) breast cancer, contribute the most to the development of fibrosis.	—

Secondary

Measure	Time frame
To assess the relation between the presence and severity of fibrosis, cosmetic outcome and different QoL domains and symptoms.	—

Contacts

Public ContactC. (Marije) A.W. Notenboom

Erasmus MC

c.notenboom@erasmusmc.nl010 704 11 16

Outcome results