Breast CancerTHORACESNCT02471079
TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study
An observational study of Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 706 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult, female patients with stage I-III breast cancer, who were treated with breast-sparing surgery followed by radiation treatment.
Who may be able to join
- 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.
Who cannot join
- Any prior malignancy other than non-melanoma skin cancer or breast cancer.
- Prior radiotherapy treatments in the thoracic region.
- Treated with neoadjuvant chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Breast Cancer
- Being tested
- Radiotherapy
- Keywords
- Radiation-induced health problems, Cardiovascular events, Lung toxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with cardiovascular events in relation with the received heart radiation dose
Measured: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Number of participants with secondary malignancies in relation with the received radiation dose
Measured: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Number of participants with radiation pneumonitis in relation with the received lung radiation dose
Measured: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Number of participants with hypothyroidism in relation with the received radiation dose
Measured: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471079
- Sponsor's protocol ID
- RT2014-02
- Acronym
- THORACES
- Status last verified
- Feb 2024
- First submitted
- 19 May 2015
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT02471079
- Acronym / sponsor ID
- THORACES / RT2014-02
- Conditions
- Breast Cancer
- Keywords
- Radiation-induced health problems, Cardiovascular events, Lung toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, female patients with stage I-III breast cancer, who were treated with breast-sparing surgery followed by radiation treatment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Any prior malignancy other than non-melanoma skin cancer or breast cancer.
- Prior radiotherapy treatments in the thoracic region.
- Treated with neoadjuvant chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy | Radiation | – |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.