Clinical trial NCT02079272: REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)
Official title: REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity): Evaluation of Radiation-induced Cardiotoxicity of Adjuvant Radiotherapy With Tomotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Heart absorbed doses
Lead sponsor: Institut de Radioprotection et de Surete Nucleaire
Sponsor class: OTHER_GOV
Collaborators: name: Institut de Radioprotection et de Surete Nucleaire
name: Institut Claudius Regaud
name: University Hospital, Toulouse
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2014-03-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels
timeFrame: within the first 2 years after tomotherapy
Secondary outcomes:
measure: Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam"2D strain")
timeFrame: within the first 6 months after tomotherapy
measure: Number of participants with modified measures of circulating biomarkers
timeFrame: within the first 2 years after tomotherapy (at the end of radiotherapy, 6 months after radiotherapy and 24 months maximum after radiotherapy)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut Claudius Regaud, Toulouse (France)
name: Carole Massabeau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Radioprotection et de Sureté Nucléaire, Fontenay-aux-Roses (France)
name: Marie-Odile Bernier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Rangueil, Toulouse (France)
name: Jean Ferrières, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Rangueil, Toulouse (France)
name: Hervé Rousseau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: