TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study (NCT02471079) | Clinical Trial Compass
CompletedNot Applicable
TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study
Netherlands706 participantsStarted 2014-09
Plain-language summary
Rationale:
The number of breast cancer (BC) patients at risk for long-term radiation-induced health problems is increasing, as their outcome is improving due to intensified treatment regimens, such as new systemic approaches and radiotherapy. Therefore, identifying BC survivors with the highest risk for radiation-induced health problems is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy ageing.
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 gender.
* Treated for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS).
* Treated with curative breast-conserving surgery followed by radiotherapy of the breast, with or without irradiation of the regional lymph nodes.
* Start of radiotherapy is between 01-01-2005 and 31-12-2008.
* Available planning CT scan and dose distribution data of original breast cancer irradiation.
Exclusion Criteria:
* Any prior malignancy other than non-melanoma skin cancer or breast cancer.
* Prior radiotherapy treatments in the thoracic region.
* Treated with neoadjuvant chemotherapy.
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
1
Number of participants with cardiovascular events in relation with the received heart radiation dose
Timeframe: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
2
Number of participants with secondary malignancies in relation with the received radiation dose
Timeframe: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
3
Number of participants with radiation pneumonitis in relation with the received lung radiation dose
Timeframe: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
4
Number of participants with hypothyroidism in relation with the received radiation dose
Timeframe: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy