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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02471079
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-15
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 706

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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
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 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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands