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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471079
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
A.P.G. Crijns, 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.


Condition or disease Intervention/treatment
Breast Cancer Radiation: Radiotherapy

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Study Type : Observational
Actual Enrollment : 706 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471079


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
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Responsible Party: A.P.G. Crijns, Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02471079    
Other Study ID Numbers: RT2014-02
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Keywords provided by A.P.G. Crijns, University Medical Center Groningen:
Radiation-induced health problems
Cardiovascular events
Lung toxicity
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases