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

Breast Cancer Clinical Trial

— THORACES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471079
• Other study ID #: RT2014-02
• Status: Completed
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 706
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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