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CompletedNCT02471079THORACESUpdated Feb 28, 2024

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

An observational study in Breast Cancer, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by University Medical Center Groningen · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
706
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer

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Keywords

  • Radiation-induced health problems
  • Cardiovascular events
  • Lung toxicity
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 706 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult, female patients with stage I-III breast cancer, who were treated with breast-sparing surgery followed by radiation treatment.

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
706 participants (actual)
Patient registry
No

Interventions

  • RadiationRadiotherapy
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What researchers measure

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

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Study locations

1 site
  • University Medical Center Groningen
    Groningen, 9700RB, Netherlands
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02471079
Lead sponsor
University Medical Center Groningen
Responsible party
Sponsor
First posted
Jun 15, 2015
Start date
Sep 2014
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Feb 28, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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