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Completed

NCT Number: NCT02471079

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherapy

Radiation

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: THORACES

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 15, 2015
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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