TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02471079

Acronym

THORACES

Enrollment

706

Registered

2015-06-15

Start date

2014-09-30

Completion date

2015-09-30

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

Keywords

Radiation-induced health problems, Cardiovascular events, Lung toxicity

Brief 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.

Interventions

RADIATIONRadiotherapy

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of participants with cardiovascular events in relation with the received heart radiation dose	At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Number of participants with secondary malignancies in relation with the received radiation dose	At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Number of participants with radiation pneumonitis in relation with the received lung radiation dose	At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Number of participants with hypothyroidism in relation with the received radiation dose	At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026