Toxicity Due to RadiotherapyREBECCANCT02079272
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)
A study testing Helical tomotherapy for breast cancer in people with Toxicity Due to Radiotherapy and Breast Cancer, run by Sophie JACOB at 1 site in France.
Trial summary
The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Toxicity Due to Radiotherapy, Breast Cancer, Lesion; Cardiac
- What is being tested?
- Helical tomotherapy for breast cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Nov 2019
- Phase
- Interventional
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women treated surgically for left or right breast cancer and for who adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly lymph node chains,
- Age between 40 and 70 years
- Adjuvant Radiotherapy is helical tomotherapy performed at Institut Claudius Regaud(Toulouse, France)
Who cannot join
- Indication of adjuvant chemotherapy
- Clinically or radiologically detectable metastasis
- Personal history of coronary artery or myocardial disease
- Personal history of breast cancer or other cancer requiring radiotherapy to the chest
- Contraindications to injection of iodinated contrast ( for CT ) : pregnancy , renal failure, allergy.
- Pregnancy, lactation
Show all 11Show fewer
- Before radiotherapy, LVEF <50%
- Before radiotherapy, longitudinal strain > - 16 %
- Before radiotherapy,longitudinal strain rate <1% / s
- Before radiotherapy, segmental wall motion abnormality
- Coronary CT before radiotherapy showing that a therapeutic treatment is required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity): Evaluation of Radiation-induced Cardiotoxicity of Adjuvant Radiotherapy With Tomotherapy for Breast Cancer
The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.
Read the detailed description
REBECCA study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the Institut Regaud Claudius-Toulouse (ICR) and followed for 2 years after radiotherapy.
In summary, women aged between 40 and 70 years, surgically treated at ICR for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.
- Conditions
- Toxicity Due to Radiotherapy, Breast Cancer, Lesion; Cardiac
- Being tested
- Helical tomotherapy for breast cancer
- Keywords
- Tomotherapy, Breast Cancer, Heart, Subclinical cardiac lesions, Myocardial lesions, Coronary lesions, Circulating biomarkers, Ionizing radiation, Heart absorbed doses
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helical tomotherapy for breast cancerOther
- At baseline, before helical tomotherapy is performed, for each included woman will have:
- measures of biomarkers of cardiac injury based on blood samples (including CRP, NT-Pro BNP, …, microparticles and miRNA)
- cardiologic examination including echocardiography for measurement of strain and strain rate
- a CT coronary angiogram for measurement of coronary plaque indexes
- Helical tomotherapy will be performed for all women included in the cohort.
- At the end of tomotherapy, follow-up will include:
- measures of biomarkers: at the end of radiotherapy, 6 months and 24 months after radiotherapy
- cardiologic examinations including a echocardiography 6 and 24 months after radiotherapy
- A CT coronary angiogram 24 months after radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Helical tomotherapy for breast cancer | Other | All women included in REBECCA cohort will be treated with helical tomotherapy for theur breast cancer.
Their cardiac follow-up will be based on echocardiography, CT coronary angiogram and blood samples Receives: Other: Helical tomotherapy for breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels
The primary outcome is defined as a decrease of at least 5% in strain or strain rate measures based on cardiac ultrasound exam"2D strain" between the measurement before radiotherapy and measures 24 months after radiotherapy and / or an increase of at least 15% in the average index of coronary plaques measured with CT coronary angiogram between the measurement before radiotherapy and measures 24 months after radiotherapy .
Measured: within the first 2 years after tomotherapy
Secondary outcomes (2)
Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam"2D strain")
Measured: within the first 6 months after tomotherapy
Number of participants with modified measures of circulating biomarkers
Measured: within the first 2 years after tomotherapy (at the end of radiotherapy, 6 months after radiotherapy and 24 months maximum after radiotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxicity Due to RadiotherapyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sophie JACOB
- Sponsor type
- Other government
- Collaborators
- French Nuclear Safety and Radiation Protection Authority (ASNR), Institut Claudius Regaud, University Hospital, Toulouse, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor-investigator, Sophie JACOB, French Nuclear Safety and Radiation Protection Authority (ASNR)
- Investigators
- Carole Massabeau, MD, Principal investigator, Institut Claudius Regaud, Toulouse (France)Marie-Odile Bernier, MD, Principal investigator, Institut de Radioprotection et de Sureté Nucléaire, Fontenay-aux-Roses (France)Jean Ferrières, MD, PhD, Principal investigator, University Hospital Rangueil, Toulouse (France)Hervé Rousseau, MD, PhD, Principal investigator, University Hospital Rangueil, Toulouse (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079272
- Sponsor's protocol ID
- 2013-A00929-36
- Acronym
- REBECCA
- Status last verified
- Apr 2015
- First submitted
- 26 Feb 2014
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity): Evaluation of Radiation-induced Cardiotoxicity of Adjuvant Radiotherapy With Tomotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT02079272
- Acronym / sponsor ID
- REBECCA / 2013-A00929-36
- Conditions
- Toxicity Due to Radiotherapy, Breast Cancer, Lesion; Cardiac
- Keywords
- Tomotherapy, Breast Cancer, Heart, Subclinical cardiac lesions, Myocardial lesions, Coronary lesions, Circulating biomarkers, Ionizing radiation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sophie JACOBOther government
- Collaborators
- French Nuclear Safety and Radiation Protection Authority (ASNR), Institut Claudius Regaud, University Hospital, Toulouse, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Nov 2014
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 5 Mar 2014 (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.
The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.
Detailed description
REBECCA study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the Institut Regaud Claudius-Toulouse (ICR) and followed for 2 years after radiotherapy.
In summary, women aged between 40 and 70 years, surgically treated at ICR for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Helical tomotherapy for breast cancer | Other | Other: Helical tomotherapy for breast cancerAll women included in REBECCA cohort will be treated with helical tomotherapy for theur breast cancer. Their cardiac follow-up will be based on echocardiography, CT coronary angiogram and blood samples |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women treated surgically for left or right breast cancer and for who adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly lymph node chains,
- Age between 40 and 70 years
- Adjuvant Radiotherapy is helical tomotherapy performed at Institut Claudius Regaud(Toulouse, France)
Key exclusion criteria (11 listed)
- Indication of adjuvant chemotherapy
- Clinically or radiologically detectable metastasis
- Personal history of coronary artery or myocardial disease
- Personal history of breast cancer or other cancer requiring radiotherapy to the chest
- Contraindications to injection of iodinated contrast ( for CT ) : pregnancy , renal failure, allergy.
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 |
|---|---|---|
| Helical tomotherapy for breast cancer1. At baseline, before helical tomotherapy is performed, for each included woman will have: * measures of biomarkers of cardiac injury based on blood samples (including CRP, NT-Pro BNP, …, microparticles and miRNA) * cardiologic examination including echocardiography for measurement of strain and strain rate * a CT coronary angiogram for measurement of coronary plaque indexes 2. Helical tomotherapy will be performed for all women included in the cohort. 3. At the end of tomotherapy, follow-up will include: * measures of biomarkers: at the end of radiotherapy, 6 months and 24 months after radiotherapy * cardiologic examinations including a echocardiography 6 and 24 months after radiotherapy * A CT coronary angiogram 24 months after radiotherapy | Other | Helical tomotherapy for breast cancer |
Primary outcome
Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels
Time frame: within the first 2 years after tomotherapy
The primary outcome is defined as a decrease of at least 5% in strain or strain rate measures based on cardiac ultrasound exam"2D strain" between the measurement before radiotherapy and measures 24 months after radiotherapy and / or an increase of at least 15% in the average index of coronary plaques measured with CT coronary angiogram between the measurement before radiotherapy and measures 24 months after radiotherapy .
2 secondary outcomes
Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam"2D strain")
Time frame: within the first 6 months after tomotherapy
Number of participants with modified measures of circulating biomarkers
Time frame: within the first 2 years after tomotherapy (at the end of radiotherapy, 6 months after radiotherapy and 24 months maximum after radiotherapy)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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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.
Carole Massabeau, MD principal investigator
Institut Claudius Regaud, Toulouse (France)
Marie-Odile Bernier, MD principal investigator
Institut de Radioprotection et de Sureté Nucléaire, Fontenay-aux-Roses (France)
Jean Ferrières, MD, PhD principal investigator
University Hospital Rangueil, Toulouse (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helical tomotherapy for breast cancer in people with Toxicity Due to Radiotherapy and Breast Cancer, run by Sophie JACOB at 1 site in France.
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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 6 Apr 2015. 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 France. 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 was withdrawn before enrolling participants, so there are no results.
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 subclinical cardiac lesions in myocardial levels and/or coronary levels (time frame: within the first 2 years after tomotherapy). 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 6 Apr 2015.