Clinical trial · Observational
TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study
NCT02471079CI-TRIAL-00074485THORACEScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- 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
- measure
- 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
- measure
- 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
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.