TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University Medical Center Groningen
- Enrollment
- 706
- Locations
- 1
- Primary Endpoint
- Number of participants with cardiovascular events in relation with the received heart radiation dose
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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-
- •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.
Outcomes
Primary Outcomes
Number of participants with cardiovascular events in relation with the received heart radiation dose
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy