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

NCT ID: NCT02471079

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

706 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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RT2014-02

Identifier Type: -

Identifier Source: org_study_id

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