CompletedNot Applicable

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)

Netherlands775 participantsStarted 2022-04-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fibrosis of the breast as measured by CTCAE v5 scale

Timeframe: 2-6 years after breast conserving treatment. 1 point of measurement.

Cosmetic outcome as measured by 9-item questionnaire

Timeframe: 2-6 years after breast conserving treatment. 1 point of measurement.

Cosmetic outcome as measured by BCCT.core software

Timeframe: 2-6 years after breast conserving treatment. 1 point of measurement.

Trial details

NCT IDNCT05263362

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-01

View on ClinicalTrials.gov More Breast Fibrosis trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Fibrosis of the breast as measured by CTCAE v5 scale

Timeframe: 2-6 years after breast conserving treatment. 1 point of measurement.

Cosmetic outcome as measured by 9-item questionnaire

Timeframe: 2-6 years after breast conserving treatment. 1 point of measurement.

Cosmetic outcome as measured by BCCT.core software

Timeframe: 2-6 years after breast conserving treatment. 1 point of measurement.